Alternatives to LICENSALE
Compare LICENSALE alternatives for your business or organization using the curated list below. SourceForge ranks the best alternatives to LICENSALE in 2024. Compare features, ratings, user reviews, pricing, and more from LICENSALE competitors and alternatives in order to make an informed decision for your business.
-
1
RegDesk
RegDesk
With the ever-increasing complexity of global medical device registration regulations, more companies are turning to regulatory information management systems software (RIMS software) to streamline the application life cycle and manage medical device applications. RegDesk is the most comprehensive AI-enabled RIMS platform for Medical Devices, Pharmaceuticals, and IVD companies offering enhanced performance and positive results more consistently than any standard regulatory information management solution. Our capabilities are as follows: • AI Application Builder • Regulatory Intelligence • Change Assessment • Standards Management • Country-Specific Templates • Distributor Collaboration • AI Document Management • Tracking & Reporting • Alerts and Notification • Product Management • Claims Management • EUDAMED For more information, visit our website. -
2
Adaptive Compliance Engine (ACE)
PSC Software
ACE is a quality management software solution for companies of any size, in any stage, in any highly regulated industry. ACE is fully configurable allowing your company to adapt ACE to fit into your exact quality needs. Empower all levels of your organization with intuitive user interfaces, easily search for all your documents and records, and transform your data into actionable intelligence with advanced analytics all on a single platform. Our one-stop software includes: -Office 365 Integration -Inspection Management -Document Management -Risk Management -Product Lifecycle Management -Learning Management -Audit Management -Quality Events -Paperless Validation -Electronic Signatures (21 CFR Part 11 Compliant) -Endless Workflow Configurations -And so much more! ACE comes with everything you need, all included at one price. Every application is included, no more a la carte pricing. No more nickel and diming. One software, endless solutions. -
3
C2P
Compliance and Risks
Compliance & Risks works with the world’s leading brands including Dyson, Caterpillar, Samsung, Miele and Tesla, to unlock market access by simplifying the Product Compliance process. We have 3 key elements to our offering: 1. C2P, Enterprise technology solution to help improve productivity & efficiency 2. Most comprehensive regulatory content in the market with over 40+ topics covering 20+ industries and 195 countries worldwide. 3. Team of Subject Matter Experts on hand to help answer any regulatory queries you need We help you monitor the relevant regulations and standards for your products and business, assess their relevance and impact, and prove product compliance to stay in market and grow your business successfully. With over 20 years of experience working with the world’s biggest brands we have an unparalleled track record of helping companies manage their compliance risks more effectively than ever before. -
4
MasterControl
MasterControl
Bringing breakthrough products to market in highly regulated industries can feel like an endless series of trade-offs. MasterControl's software simplifies GxP workflows so you never have to sacrifice quality for cost or innovation for regulation. Complete and connected meets fast and flexible. From quality event management to document control and integrated training - MasterControl Quality Excellence transforms your quality data and processes into a competitive advantage. Modernizing your manufacturing operations starts with modern software. From work orders to work instructions and production records (EBR or eDHR) to logbooks, MasterControl Manufacturing Excellence is the simplest way to digitalize manufacturing.Starting Price: $25,000 / 1st year -
5
Regislate
Arazy Group
Everything you need to successfully register your medical device or IVD product in any market around the world and manage your market access license through the product life cycle. REGISLATE® provides users with medical and IVD device-specific at country-specific complete submission file requirements. Users can manage milestones, timelines and estimated and actual completion dates for initial registrations, renewals, amendments and license transfers in real-time. Infographic data and proprietary indicators for clear monitoring and management of each project are available. Utilize collaboration tools for preparation and review of submissions, compliance requirements and documents. Recieve progress reports in real-time for current and future submissions including market access readiness index. REGISLATE® includes GR-MAP registration tracking for both country and product. -
6
Essenvia
Essenvia
Essenvia drives business value and brings cross-functional efficiency gains to all teams and departments. Centralized repository for all regulatory information, enabling collaborative authoring and reporting while eliminating technical holds, RTAs, and RFIs. Empowerment of regulatory affairs department to accelerate product launches and eliminate revenue loss due to submission delays and missed renewals. Helicopter view of the total regulatory lifecycle. Executive dashboards, metrics, and proactive alerts for global registrations, submissions, and change assessment. Essenvia is a RIM Platform that enables you to manage regulatory workflows across the total product lifecycle, accelerate global market access, and generate exponential business value. Consolidate your regulatory activities into one centralized platform and bring your devices to market faster. Central repository for all registration docs linked to product master data. Manage product registration lifecycle by country. -
7
ClinChoice
ClinChoice
ClinChoice manages global regulatory information with expert technology prowess, a deep understanding of global and local regulations, and the best data management practices. ClinChoice applies its expertise in regulatory affairs and technology to help organizations manage their regulatory data. Our consultants provide general data maintenance support in regulatory information management system (RIMS) software to deliver solutions that will ensure application submission, approval, renewals on time, improve operational process efficiency and tracking. We provide the required support in the management and control of the drug registration process, which helps the drug and medical device manufacturing companies to have visibility and tracking of all regulatory information. With our help, organizations can develop short- and long-term strategies to meet submission timelines with minimal impact on day-to-day operations. -
8
Rimsys
Rimsys Regulatory Management Software
Rimsys is bringing regulatory order to the medtech industry. The Rimsys Regulatory Information Management (RIM) platform digitizes and automates regulatory activities, freeing teams from inefficient administrative work, and helping them confidently establish and secure global regulatory compliance. Unlike complex, color-coded spreadsheets, or expensive external consultants, Rimsys seamlessly centralizes all regulatory information, automates submission processes, and monitors relevant expirations, standards, and global regulations. Traditional approaches to regulatory affairs can’t keep pace with the growing complexity of the global landscape, and overburdened teams face increasing compliance risks. Rimsys streamlines all regulatory activities including registrations, essential principles, UDI, standards management, and regulatory intelligence in a single, integrated platform. -
9
PhlexRIM
Phlexglobal
PhlexRIM will dramatically improve compliance with efficient and effective real-time access to your global registration information. PhlexRIM 2.0 contains a library of pre-configured automation assistants, or “bots,” as well as built-in regulatory use cases based on industry best practices. Utilizing an intuitive drag-and-drop design tool, regulatory teams can automate their business processes without programming knowledge or IT support. Manage the lifecycle of pharmaceutical product registration activities. Get extensive status information and use the alert management which is included in all workflows. Illustrate reports using standard reports or design your own reports. Create and assign regulatory tasks across your organization – for management, departments, headquarters, and affiliates. -
10
ViSU
DDi
ViSU™ is a cloud based End-to- End Regulatory Information Management (RIM) platform designed specifically for the medical device industry enabling global users to access and manage Regulatory Data (Product Master, Registrations, Tracking), Dossiers/Tech Files (Submission planning, building & life cycle), HA/NB correspondence, Obligations tracking, UDI, eIFU, Reg Requirements DB and Change Control. ViSU helps you embrace digitization in regulatory that delivers connectivity, traceability and automation leading to regulatory management efficiency, less compliance risks & cost reduction. -
11
Samarind RMS
Instem
Samarind RMS provides a smarter way to manage your medical product information. Using Samarind RMS, you only need to enter data once and can reuse it as many times as required. For example an ‘INN’ can be entered once and reused for all related IMA submissions, renewals, variations, PSURs and XEVMPD submissions. This concept applies to all key data held within the system and is proven to streamline workflows and help to increase data quality. Our pragmatic approach to systems design and implementation means that our customers can manage their licenses smoothly and efficiently, safe in the knowledge that our single-place-of-truth™ approach for regulatory affairs professionals delivers a complete end-to-end system. An electronic document management system (EDMS) with version control, template creation and the ability to link to external document management systems such as Documentum™ or SharePoint™. -
12
RIMTrack
WinWire Technologies
With ever-changing national regulations, data standards, and complexities around preparing for regulatory submissions, regulatory affairs organizations in the healthcare and life sciences industry are convinced and driven towards smarter processes and intelligent systems to optimize costs, maximize accuracy and minimize timelines for the submission. Addressing the concern, regulatory information management, RIMTrack, is a cloud-ready artificial intelligence (AI) based new age regulatory information management system. It’s developed from scratch with the mission to help organizations to prepare submissions accurately and efficiently and by streamlining the regulatory processes related to tracking, licensing, approvals, regulatory and competitive intelligence, clinical trials, and reporting across global sites and stakeholders. Integrate with existing RIM system and achieve complete end-to-end management of regulatory life cycle process. -
13
Veeva Vault RIM
Veeva
End-to-end regulatory information management on a single platform. The Vault RIM Suite streamlines global regulatory processes on a single, cloud-based platform, enabling life sciences companies to improve visibility, data quality, and agility. Respond faster to changing regulations and increase process efficiency from submission planning to publishing. Coordinate regulatory efforts across HQ, affiliates, and partners within a single RIM system. Ensure teams are developing reliable regulatory content with high data integrity. Veeva Vault Registrations manages product registration data worldwide, including registration status, variations, and health authority interactions. Veeva’s flexible data model accommodates IDMP data points and will continue to support evolving regulatory data standards. Veeva Vault Submissions streamlines submission planning through approval by automating regulatory process steps. -
14
LifeSphere RIMS
ArisGlobal
Accelerate speed to market by planning, executing, and tracking all regulatory activities in a single, unified RIM application, with seamless access to regulatory documents and full support for all major eCTD submission requirements. Built-in automation streamlines workflows to reduce administrative burden and provide greater confidence in product registration data quality. Accelerate speed to market by planning, executing, and tracking all regulatory activities in a single, unified RIM application, with seamless access to regulatory documents and full support for all major eCTD submission requirements. Built-in automation streamlines workflows to reduce administrative burden and provide greater confidence in product registration data quality. -
15
Kalypso Accel for RIM
Kalypso
Kalypso provides life sciences companies with a cost-effective accelerator for a RIM system implementation - Accel for RIM. The solution enables an integrated platform to effectively manage and track product registrations, accelerate and improve the submissions accuracy, manage global UDI information, and enable efficient product distribution. It consolidates compliance and quality data from various enterprise solutions into a global source of truth for product registrations and tracking to accelerate regulatory submissions. Deployed using modern APIs to aggregate product data, regulatory documentation and submission packages. Pre-configured for rapid implementation with a validated software system. Based on industry-leading RIM practices and implementations. -
16
Ennov RIM
Ennov
Imagine all of your regulatory information regarding products, registrations, submissions, correspondence and commitments in one centralized place accessible from anywhere. With Ennov RIM, life sciences companies can streamline their regulatory processes, improve their data quality, quickly answer business-critical questions and effectively respond to health authority requests. Ennov RIM is a purpose-built application (based on Ennov Process) for the management and tracking of therapeutic product details and registration information. Whether you are planning the launch of a new product or handling variations to existing registrations, Ennov RIM provides Regulatory personnel with the key information and functionality to effectively manage your product portfolios worldwide. -
17
DXC RIM
DXC
DXC RIM platform manages regulatory affairs content, data, and workflows in one central location, helping teams accelerate innovation and reduce time to market. The sensitive nature of regulatory affairs (RA) content demands a unified platform to handle regulatory data and workflows. Teams need simple, always-ready access to all relevant data. They also require an intuitive, customizable user interface that is easy to navigate. Collaborative tools and configurable reporting are crucial for success, but legacy technology can frustrate teams and slow processes. Achieving compliance is a struggle. Collecting data and documenting processes is time-consuming. Problems are compounded when life sciences organizations run fragmented legacy systems using disparate technologies. In some cases, they need to resort to spreadsheets to manage key operational processes. Bringing products to market and managing RA requires a centralized, enterprise-grade solution. -
18
RegDocs Connect
Montrium
RegDocs Connect gives your operational and regulatory teams the tools they need to prepare complete and compliant submission ready documents and records. Built with the end user in mind, collaboration, automation and quality are the foundation of this solution. Automated workflows manage your records lifecycle from draft to final, enabling your team to be in complete control of your regulatory documents at all times. Mapping of document types to the EDM reference model and eCTD facilitates organization and retrieval of documents for inclusion in regulatory submissions. Proprietary tools such as PDF/A Publishing, document classification, and unique document identifiers provide a powerful regulatory document management solution that pulls information from across your organization, into one manageable solution. With the rise of electronic submissions to regulatory agencies and the increased complexity of drug development, the ability to produce submission-ready, quality content -
19
RIMExpert
AMPLEXOR
RIMExpert™ addresses regulatory planning, tracking and data management by managing the global rollout plans and automating the creation of regulatory applications, activities and medicinal products, RIMExpert™ reduces data entry needs, improving data quality and increasing global oversight and control. Standardize regulatory planning, tracking and registration management processes. Strengthen collaboration between headquarter(s) and affiliates. Create one common place to work in all registration activities. Having one access point to all activities, questions, commitments, correspondence and authorizations for every application. Synchronize efforts for maximum efficiency of enterprise regulatory resources. Control registration activities throughout the lifecycle of the product keeping abreast of timelines and status of commitments and agency questions. Interactive dashboards for actionable regulatory activities and registrations overview. -
20
IQVIA RIM Smart
IQVIA
Streamline your regulatory processes with our new, end-to-end regulatory information management system, IQVIA RIM Smart. Free your team from labor-intensive maintenance to focus on delivering valuable products to market. RIM Smart is the modern regulatory information management solution built to increase speed, collaboration, efficiency and visibility across your entire global portfolio, improving performance at a lower cost. Delivered securely in the cloud, IQVIA RIM Smart provides interconnected, comprehensive and intelligent management of the entire regulatory process. IQVIA safety and quality platform integration will heighten performance and enhance flexibility. Automate manual processes and increase connectivity for improved efficiency, cost savings, and better coordination and cross-enterprise visibility. -
21
Dow Jones Risk & Compliance
Dow Jones Risk & Compliance
Dow Jones Risk & Compliance is a global provider of best-in-class risk data, web-based software applications and scalable due diligence services that help organizations manage risk and meet regulatory requirements related to financial crime, third-party risk management, sanctions and international trade. Built on the legacy of one of the world’s most trusted newsrooms, Dow Jones Risk & Compliance combines the expertise of a multilingual research team with industry-leading data scientists and technologists to provide actionable content structured specifically for compliance needs. Our solutions were developed in partnership with top legal and political advisors — including former regulators — to help our clients maintain consistency across global business units and teams. -
22
Accruent Meridian
Accruent
Keep all your documents and drawings in one place with our top-performing enterprise document management software. Meridian provides a single source of truth, configurable workflows to streamline collaboration with all internal departments and ensures every document change is versioned and audited to demonstrate regulatory compliance. Engineering document management is the process of effectively searching for, finding and managing the complex engineering documents – including CAD files, drawings, designs, technical documents and communication documents, that exist in AEC organizations (Architecture, Engineering & Construction). Effective engineering document management can often be difficult for businesses in these industries. Meridian’s document management system for engineering projects can resolve these concerns. Meridian can centralize an organization’s relevant documents and drawings while automating key processes. -
23
OneVault
Donoma Software
Secure Multi-Data Archiving from a Single Interface OneVault archives email AND all the new data types your organization uses today. Email, Instant Messaging, Teams, Zoom, Webex & more. With OneVault you get a single interface to archive from many systems. Important data is centralized in a secure cloud platform that makes it easy to orchestrate consistent policies that also supports your business continuity plans. The single pane of glass for managing and working with records makes e-Discovery process secure, accountable, and best of all, intuitive to use. OneVault incorporates the powerful features of our stand-alone archiving solutions under a single pane of glass in an intuitive, secure, and scalable system. Start with email, expand as new systems are adopted where retention will either be required for compliance or just for ensuring access to de-facto operational commitments.Starting Price: $2.50/month/user -
24
AmpleLogic Regulatory Information Tracker is built on the LOW CODE AND NO CODE (LCNC) PLATFORM and comprises two modules: ANDA and DMF Tracker. This Pharmaceutical RIMS Software can help you improve the quality of your data, boost operational efficiency, decrease mistakes, and streamline communication across departments.
-
25
harmon.ie
harmon.ie
harmon.ie makes it easy for knowledge workers to capture and classify emails and documents to SharePoint and Teams directly from Outlook, the place they already spend their work time. As such, it is easy to discover and share important content when needed, right from the email client. By making it easy to do the right thing, harmon.ie increases SharePoint adoption, workplace productivity, as well as information governance and compliance. That is why thousands of enterprise customers count on harmon.ie's SharePoint and Office 365-based user experience products for email and records management, collaboration, knowledge retention, and SharePoint adoption. harmon.ie has won numerous Microsoft Best App awards and is a long time Microsoft Partner. Our flagship solution breaks down data silos from Office 365 apps, by grouping information using Descriptive Labels. harmon.ie SmartAssistant helps organizations bring together all their information so employees can focus on workStarting Price: $6 per user per month -
26
EXTEDOpulse
EXTEDO
EXTEDOpulse is a comprehensive RIM software solution consisting of five hubs that address every step of pharmaceutical product development. Use the applications individually or gain additional value by using them together based on your requirements. Developing pharmaceutical products can be a multi-faceted process, involving input and efforts from across an organization. The complexities of operating within a highly regulated industry only further compound the challenges that a life science organization faces with every release. Having our finger on the pulse of the life sciences anatomy allows us to provide you with great synergy, connection and innovation for effortless compliance. EXTEDOpulse has been designed with these aspects in mind to help you connecting the dots throughout the entire lifecycle of pharmaceutical products. EXTEDO understands the complexities of the regulated pharmaceutical product journey. -
27
Regulatory functions hinge on high-cost contributors across a variety of regulatory content. A cloud-based offering like Infosys regulated document management platform is the perfect solution to this problem. Externalization, collaborative authoring and editing. Simplify governance, processes, and implement consumption-based commercial model; provide support for audit trails. Create custom workflows, and provide support for versioning; implement a proven solution with 99.95% guaranteed uptime in production. Our solution enabled business users to search documents from a vast repository within 3/4 seconds. The new system also offered users unlimited on-demand storage. The DMS uses Google application programming interfaces (APIs) to reduce operational and maintenance costs. The company’s overheads are limited to API usage and storage space.
-
28
Calyx
Calyx
At Calyx, we know that the success of your clinical development program comes down to data. Which makes the effectiveness of your electronic data collection (EDC) system key. Used in over 2,600 worldwide clinical trials, Calyx EDC streamlines clinical trial data collection and reporting—in one easy-to-use platform. Don’t trust your important data to just anyone. Contact us to learn how Calyx can propel your program’s success. Calyx EDC gives you the flexibility to easily plan, design, and conduct studies, regardless of their complexity. With features that help reduce costs, improve site visibility, and drive efficiency, Calyx EDC keeps your trial on track. -
29
LORENZ RIM
LORENZ
Choose just the solutions you need right now. Later on, you will be able to add more capabilities with no problem. The LORENZ Foundation handles Controlled Vocabularies, Repository Management, Interoperability Management and User Management by centrally streamlining system management as well as maintenance and deployment. Benefit from a network of specialized systems that harmonize with each other. LORENZ solutions work flawlessly with third-party software, giving you the flexibility to choose your perfect fit even outside of the LORENZ portfolio. -
30
RecordPoint
RecordPoint
The RecordPoint Data Trust platform helps highly regulated organizations manage records and data throughout their lifecycle, regardless of system. The customizable platform is comprised of records management and data lineage tools that work together to give you full context of your data. RecordPoint’s capabilities span six core areas, which are the essential building blocks for solid data governance - data inventory, categorization, records management, privacy, minimization, and migration. -
31
RQM+
RQM+
RQM+ is a global medical technology service provider focused on accelerating compliance and market success. Through our unparalleled expertise and industry knowledge, we deliver specialized solutions and expedite the journey along the full product lifecycle for medical technology companies, from concept to commercialization to post-market. Our portfolio of services enables the delivery of end-to-end solutions across the complete medical device product lifecycle. RQM+’s quality assurance engineers review material lists, set up suppliers, and support the design change process. RQM+’s design quality engineers help support packaging, sterility, biocompatibility, and device testing that may be needed. RQM+’s regulatory affairs consultants provide guidance and help with submissions to the FDA, notified bodies, or other government agencies. We use our extensive experience with the latest reimbursement requirements and value-based compensation models. -
32
meddevo
dytab GmbH
Discover a new way to manage the technical documentation of your medical devices with meddevo, a cloud-based tool crafted for the medtech industry. Seamless Digitization: Completely transform and automate your regulatory affairs process, ensuring you're always aligned with international standards, including EU-MDR, EU-IVDR, and ANVISA. User-friendly Experience: Using meddevo is as straightforward as filling out an online form. No steep learning curve, ensuring a smooth onboarding for your team. Effortless Integration: Import and export data with ease, making integration into your current systems straightforward. Top-tier Security: Hosted on the robust AWS platform, meddevo prioritizes your data's security. Activate 2-Factor Authentication (2FA) for an added layer of protection. Unrestricted Trial: Experience all that meddevo offers during the free trial, ensuring a comprehensive understanding of its capabilities.Starting Price: 249€/User -
33
TopSource Worldwide
TopSource Worldwide
TopSource Worldwide’s in-country experts help you hire and manage your international employees. Our in-country experts ensure all your international HR and payroll needs are taken care of through our end-to-end services. Real, knowledgeable people providing accurate employment advice. Fast, responsive, and reliable service with robust SLAs. Supporting every step of the employee lifecycle, from hire to retire. Centralized account management with a single point of contact. Access local HR & payroll experts in every location. Onboard new global talent in days, not weeks. A dedicated team of employment experts to take care of all your needs. A single, global tech platform for all your hiring requirements. Easy-to-use tech platform that integrates with your existing HR software. Complete employment contracts and management of employee benefits through our established entities. We handle compliance and the entire hiring & onboarding process from payroll to termination where required. -
34
OpenText for Life Sciences
OpenText
OpenText™ Information Management solutions help life sciences organizations leverage insights from data and content to improve decision-making processes and accelerate product development. Integrate, manage, and securely exchange data across people, systems and things. Leverage information assets from R&D to commercialization. Freedom of choice with cloud-native software that can run anywhere. OpenText for life sciences accelerates the discovery process by extracting actionable insights that drive pipeline innovation. Capture and manage research papers into electronic lab notebooks with intelligent capture. Find insights with text mining. Extract knowledge trapped in the unstructured text contained in clinical trial reports, study protocols, clinical safety and efficiency findings. Find out how to intelligently analyze, classify and extract clinical trial documents to reduce the risk of costly stops and starts. -
35
BrightInsight
BrightInsight
BrightInsight accelerates time to market for our customers’ digital health products, including apps, algorithms, medical devices, connected combination products, diagnostics, and Software as a Medical Device (SaMD) across therapeutic areas. BrightInsight replaces the need for lengthy and complicated ‘build from scratch’ implementations and instead offers a pre-built and proven digital health platform designed under a Quality Management System to support global security, privacy, and regulatory requirements. We helped Roche launch a Software as a Medical Device (SaMD) dosing calculator for hemophilia A in 6 months in Europe, and accelerated a Top 10 Biopharma companies remote patient platform from project kickoff to commercialization in less than a year. We are experts at building and maintaining biopharma and medtech regulated digital health products, with multiple commercial launches in the last year alone. -
36
STEMSOFT Software
StemSoft Software
STEMSOFT is a leader in the field of medical informatics, providing end-to-end information management, quality assurance, and regulatory compliance solutions to cell therapy manufacturers, hospital-based cell therapy programs, and family and public cord blood banks. By creating innovative software, we empower healthcare providers to discover and deliver effective treatments. Access predictable and proven training programs that include value-added consulting services. Qualified resources and industry experts provide the specialist knowledge and expertise you need. STEMSOFT Certified Partners offer complementary products or services that help to streamline your everyday workflow and assist with regulatory and accreditation requirements. -
37
Our SmartInsights™ Global Market Access Platform is an online subscription service created for you to quickly and easily access current, accurate and complete regulatory requirements for global market access. The information is presented in a user-friendly interface tailored to help you achieve global compliance. Immediate access to critical regulatory data and information for effective day-to-day management of multistage product development life cycles and strategic business decisions, such as entering new geographic markets or introducing a new line of products. Up-to-date information on an ever-changing regulatory landscape, with easy access to new or updated regulations for your product category. Information in the database is continually updated to provide you with timely and current requirements. Access is customized based on the countries and product categories you need.
-
38
Gov2Biz
Gov2Biz
Gov2biz is a comprehensive regulatory agency management solution that brings all your licensees and employees, rules and regulations, data, and documents on one platform. Software to power the government, delivered from a cloud platform built exclusively for the government. Online applications, issuance, renewals, amendments, assessment, reporting, aggregation, reconciliation, and payments. Everything is in one place. and regulatory controls. A complete feature set for regulating product labels, registration, and branding. An all-inclusive case management solution for law enforcement organizations. Complete hub of easy-to-use software solutions for local governments. Gov2biz is a cloud-based and SaaS-delivered regulatory agency management platform. With all your and your licensee’s regulatory functions in one place, Gov2biz is the only software you will ever need. Gov2biz is responsive to all screen sizes. -
39
Karomi
Karomi Technology
Karomi offers a cloud-based packaging and artwork lifecycle management system for Pharmaceuticals and Consumer Packaged Goods(CPG) companies. Our platform introduces efficiencies in every step of your artwork's journey - starting from collating content, designing the artwork, having it reviewed and approved by your internal and external stakeholders, and finally releasing it to your markets. As a result, it helps organizations in regulated industries reduce reworks and approval times, achieve compliance, and significantly reduce their product’s time-to-market. The system can be used by all internal department users like Regulatory, Packaging, QA, Marketing, R&D, Medical Affairs, Legal, etc. and by external stakeholders like print vendors, artwork studios, LLPs, 3rd party, CMO and CPO. Graphics, Text, Barcodes, and Braille can all be inspected and compared across artworks. The measurement tool allows accurate measurement of lengths & areas and the annotation tools. -
40
Veeva Vault PromoMats
Veeva Systems
Built-in digital asset management for life sciences enables global reuse and reduces spend on promotional materials. Marketing teams can easily publish and withdraw content to digital channels and ensure only approved assets are in use. Accelerate content approval and time to market with industry-leading medical, legal, and regulatory (MLR). Built-in claims library with reference links reduces the administrative burden and risk of managing claims across countries, channels, and assets. Our industry cloud solutions provide data, software, services and an extensive ecosystem of partners to support your most critical functions from R&D through commercial. Veeva helps companies of all sizes bring products to market faster and more efficiently and maintain compliance. -
41
Greenlight Guru
Greenlight Guru
Greenlight Guru’s Medical Device Success Platform is the only all-in-one solution that helps you get your products to market faster, with less risk, and advance your success in-market. The platform helps companies manufacture safer products and get to market faster, simplifies regulatory compliance, and provides a single source of truth by connecting the management of all product development, regulatory, and quality processes from documentation and design controls to submission and ongoing compliance. Device makers across the globe are replacing reactive quality management tools and shifting their focus and efforts to ensure successful product launches and in-market success of innovative, life-changing devices. -
42
BIPO HRMS
BIPO
Intuitive, cloud-based platform automates the entire on/off-boarding process. Global HR and payroll outsourcing in 100+ countries with full local service delivery and expertise. With built-in calculation and compliance capabilities to manage your global workforce. One-stop HR hub and outsourced payroll services to manage your global workforce. Delivering the best-in-class local support across 100+ countries so you can focus on growing your business. Scale your business globally without the complexities of multiple HR service providers. HRMS platform with built-in compliance capabilities, supported by our in-country HR and Payroll experts. Manage end-to-end HR and payroll processes on our ISO-27001 certified cloud-based platform. A global networks across 100+ countries to support your business 24/7 from anywhere in the world. -
43
Ennov Regulatory Suite
Ennov
Ennov Regulatory Suite, a world-class regulatory content and information management is a unified, centralized, end-to-end solution that is robust enough to support the regulatory information workflow from the earliest stages of research and development through market authorization. It is a common principle shared by companies striving to achieve regulatory operational excellence. These companies understand that an such a solution will help them drive harmonization, promote standardization, improve collaboration, ensure compliance, eliminate waste, reduce costs, accelerate product release and allow them to operate and compete more effectively in global markets. The Ennov Regulatory suite combines the power and flexibility of Ennov Doc, Ennov Dossier and Ennov Process to support the entire regulatory product lifecycle from the early planning of registration targets through product retirement. The Ennov Regulatory suite is an invaluable tool for regulatory activity planning. -
44
InCountry
InCountry
Transform your applications to enable local compliance and security. Map your controls and improve your compliance program while still leveraging the cloud. Enable your custom apps to meet data residency requirements with minimum to no extra development. Enter new markets and drive revenue without disrupting your customer experience. The InCountry platform keeps yout financial services applications compliant with data regulations in more countries, so you can make the most of them. Protect your path to precision medicine with a modern data compliance platform. Accelerate research—and time to discovery—with healthcare focused solutions from InCountry. Enter new markets and drive revenue without disrupting your customer experience. The InCountry platform keeps your sales process fully compliant with local data regulations. -
45
Armadillo
The Armadillo Group
Take the stress out of KYC & AML compliance with our tailored, comprehensive regulatory solutions. Full compliance assistance & management. Protect, maintain and improve your brand. Brand audit & protection, Trademark registration, oppositions & defence. UK & Worldwide company formation & administration services, cost effective legal solutions, UK accountancy & audit, company secretarial and compliance assistance. Added to this we have an extensive database of companies and so can provide documents and information from all jurisdictions globally; which is why customers choose us for their support. -
46
QMENTA
QMENTA
Globally accessible, infinitely scalable, AI-powered, collaborative cloud platform meeting the highest standards of security and compliance. An industry-leading and simple-to-use software platform, purpose-built by neuroimaging and data science experts to meet the distinct and challenging needs of the neuroscience community. Optimized and tailored for your needs, whether you are conducting research, running clinical trials, at the point of care, developing novel algorithms or leveraging brain-related data. Global data aggregation, and consolidation of imaging-based studies in one cloud platform. Streamlined, end-to-end clinical, real-world data and medical imaging data management. End-to-end expert and personalized support to ensure your study success. Centralized reading and the ability to compare quantitative results to a normative database. Highest quality, shareable reporting and data exporting for submissions approval. -
47
Global Expansion
Global Expansion
Streamline your global operations and save money by leveraging Global Expansions' Employer of Records services, allowing you to reduce expenditure on HR, legal and finance personnel while keeping compliance in check. Say goodbye to costly in-country infrastructure setup expenses! Global Expansion’s EOR platform and support services allow you to quickly hire legal, full-time workers in a new country without having to first establish a local business entity. On paper, the worker is employed by us, but in every meaningful sense, they work for you. Our platform accurately automates compliance to protect you and your company. Managing an international workforce is complex. Our global HR experts are based around the world, and with you every step of the way. We ensure that you can onboard team members in new countries with confidence, ease and expeditiousness. -
48
GlobalSubmit
Certara
Whether you are experienced or new to the regulatory submission process, the risk of rejection of your electronic common technical document (eCTD) submissions cannot be taken lightly, especially given the changing and growing complexity of the regulatory environment. Not to mention, differences in eCTD submission criteria per region, managing the entire document lifecycle and meeting your organization’s goals on expediting your release to market. With Certara’s GlobalSubmit™ eCTD submissions management software, you’ll provide your regulatory team the tools they need to efficiently publish, validate, and review your eCTD submissions. This means you can eliminate risk and avoid unnecessary steps with a simplified eCTD submission process that supports your regulatory team as they race to meet deadlines and deliver treatments to patients. As your regulatory department races to meet deadlines and deliver treatments to patients, it’s crucial that you file your eCTD submissions. -
49
Yordas Helix
Yordas Group
Welcome to Yordas Helix, our proactive product risk and regulatory intelligence management system. Helix is designed to help you take control of market access and change, and gain transparency across your supply chains globally. Created as a reflection of our company values, Helix brings together our scientific and industry knowledge and our collaborative spirit to deliver an innovative solution to help you overcome your regulatory challenges. We want to provide you with an easy-to-use platform that is tailored to your specific business needs. Helix is more than a name; it's a symbol of our dedication to data-driven innovation. It unites our expert consulting with an interactive digital solution to deliver unparalleled insight into continuous chemical compliance and risk management. Helix brings together your product information with our wealth of regulatory experience and compliance data and empowers you with the ability to evaluate the impact of change on your products and business. -
50
Ascent
Ascent RegTech
Regulatory monitoring, made simple. View, search, and organize regulatory content from around the world, all in one place. Monitor and prioritize regulatory changes that apply to your business. Rule Updates, Filings, Proposals and Amendments are all included, so you’ll never be surprised by a new or updated rule. See documents organized by industry-standard themes (such as cybersecurity or AML) or by your own custom themes. Work the way you want for clearer insights into emerging regulatory trends. Mark documents and assign them to teammates for review. Create and manage your own obligations so you can track work and ensure completion. All rule updates, guidance notes, speeches and other regulatory documents are consolidated in one place. Documents are organized by key regulatory themes to reflect how Risk and Compliance Officers actually work. Save 20+ hours per regulation in monitoring rule changes. Ascent surfaces the information you care about.