Essenvia Alternatives

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.

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.

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.

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.

All-in-one global regulatory affairs system, complete with registration management software and worldwide assistance from regulatory experts. The registration system you need to initiate, renew, amend or transfer your medical device or IVD market access approval. LICENSALE®‘s intuitive user interface with real-time data includes complete project management, infographic analytics, an effective collaboration platform, future market access planning and advanced reporting. It puts you in control of your global medtech registration activities. Arazy Group “in-country” regulatory experts review your compliance documents, assisting in the preparation and submission of your applications. They work with authorities until you obtain your desired marketing approvals. LICENSALE® includes submission and compliance requirements specific for your product in over 140 countries as well as regulatory experts to assist with each of these markets.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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™.

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.

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

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.

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.

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.

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.

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.

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.

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.

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.

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.

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 work

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.

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.

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.

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.

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.

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.

Configuring and managing ADCs has always been a tedious, expensive affair. Complicated processes, the need for technical expertise, lack of centralized management, and long ticket queues have traditionally caused service delivery delays and the TCO (total cost of ownership) to go up. AppViewX ADC+ provides GUI-based, API-driven, out-of-the-box solutions that simplify and speed up ADC lifecycle automation. ADC+ pushes all the technical nitty-gritty of diverse infrastructures under the hood and provides standardized, highly abstracted solutions that can be self-serviced by business users as well. The application delivery services have evolved exponentially over a while, demanding LBaaS fulfillment to abstract the underlying infrastructure complexity by automating load-balancer (ADC instances) provisioning end-to-end, which traditional solutions cannot do independently.

Binocs is the global leader in digital planning, scheduling and performance management for life science organizations Our cloud-based system is used by more than 1,500 teams worldwide, in areas such as QC labs, QA departments, R&D labs, CGT production, CDMOs, clinical operations, and regulatory affairs. Clients such as GSK, Pfizer, J&J, Merck KGaA and Novartis have elevated their resource management and enhanced productivity, improved service levels, and increased employee retention with Binocs

Devex Product Lifecycle Management (PLM) for process industries provides integrated tools and processes that boost the visibility, harmonization, validation and traceability of the data and actions performed at each stage of your product lifecycle, all contained inside of a single, centralized system. With Devex PLM, you can bring better products to market faster, with lower costs and with higher safety. Devex PLM maximizes the performance of individual departments and promotes mutual collaboration. It removes pockets of inefficiency by providing world-class, industry-proven solutions tailored for your specific business needs. Devex PLM covers the all areas of product development, from idea to label: Product Portfolio Management (PPM), Regulatory Compliance, Product Data Management, Product Formulation, Specification Management, Labeling and Supplier Relationship Management. Selerant has designed each Devex PLM module to support a winning user experience.

Achieve better visibility across the contract lifecycle. Manage contracts with more intelligence. ESM Contract helps you master the contract lifecycle by providing a central repository where contracts can be stored and managed more efficiently and securely. With better processes supported by automated workflows, controls, and notifications, you can track spend more effectively, improve compliance, and leverage negotiated contracts to deliver more value to your education community. ESM Contract improves visibility into contractual agreements across your institution. Establish alerts and notifications to monitor the remaining value of a contract, review contract renewals, and understand when contracts are about to expire. With a centralized contract repository, you can understand what agreements have been put into place and leverage the benefits of those contracts more effectively on behalf of your education community.

Ensuring product safety, managing regulatory compliance and promoting responsible design, development and management of products throughout their lifecycle is a difficult job. Increasing consumer scrutiny and shrinking resources make it even harder. With Verisk 3E™ as your single trusted source for global regulatory expertise and compliance solutions you will be able to proactively anticipate and manage regulatory changes, respond quickly to changing customer requirements, avoid supply chain disruption and accelerate time to market. We deliver the most comprehensive and powerful suite of intelligent compliance solutions for product safety and stewardship. With limited resources, continually changing regulatory obligations, rapid fire customer demands, and information locked in siloed systems, R&D professionals are required to be more agile than ever before.

Standardize and automate the contract lifecycle—from initiation, creation, negotiation, and execution, to expiration. Empower users with end-to-end visibility of contracts across your organization for improved compliance, lower risks, and higher employee productivity. Leverage our automation tools to enable smarter contract authoring and contract information tracking. Automated processes, including contract authoring, review, registration, renewal, termination, and request for contract addendums. Tracking of results from public expenditures to ensure that payment is commensurate with performance. Escalation matrix, imported from the customer’s active directory, to automatically define escalation structure. Clause repository, containing data related to contract clauses, like clause ID, name, and content.

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.

Empower employees to establish and build new social relationships and create synergies within the ecosystem that accelerates business goals. Identify, engage and nurture priority prospects through social media assets of your workforce. Deeper insights around brand perception and convergence of big data to business strategies, enabling manager to take a better informed decision around marketing and product practices. Monitor employee posts engagement & reach, with metrics such as engagement value, earned media value and LTV (Life-time value). Create a centralized wiki in the form of learning forum for brand’s marketing & sales collateral repository in the form of PPT, whitepapers, reference materials etc. Tap into the customer lifecycle and engage with customers, potential customers, brand evangelists, target audiences with specific, personalised and humanised brand voices.

One Platform to Research, Document, and Collate your Clinical Data. Simplify your research data with the Nucleus platform. A single platform to store your study documentation, clinical datasets, submission data and compliant media. Nucleus Documents enables document management and version control for your quality documentation and media. Control, manage, and share company content with ease. Collate and control your electronic trial master file documents with ease using our centralized regulatory document management solution. Nucleus Coding enables dictionary term coding against both MedDRA and WHODrug dictionaries, either in our standalone application, or integrated into your data capture system.

Cloudbyz Safety & Pharmacovigilance Solution is a cloud-based software solution designed to streamline the drug safety and pharmacovigilance operations for pharmaceutical and life science companies. The solution helps to automate the process of collecting, processing, analyzing and reporting adverse event data in compliance with global regulatory requirements. Cloudbyz Safety & Pharmacovigilance Solution enables companies to reduce risk, improve compliance, and enhance patient safety while accelerating drug development. Cloudbyz provides end-to-end management of the pharmacovigilance lifecycle, including adverse event processing, case management, regulatory reporting, signal detection, and risk management. With Cloudbyz, you can optimize your pharmacovigilance processes, accelerate case processing, and increase the accuracy of your safety data, while minimizing risk and ensuring compliance.

Automate the end-to-end claims journey, from intimation of the first notice of loss and fraud detection to claims adjudication, and finally claims settlement. Experience the flexibility of addressing various claim types differently, like death and maturity claims, while improving regulatory compliance and eliminating non-compliant penalties. Enable faster, accurate, and effective processing through data capture, payment tracking, salvage and recovery tracking, legal matter processing, monitoring, and more. Effective registration, adjudication, tracking, and management of claim submissions. Built-in, comprehensive business rules for automatically categorizing claims as “fast track” or “non-fast track”. Flexibility to add or modify stakeholders— garages, assessors, loss adjusters, surveyors, investigators, claim officers, etc.

With Accelerate Spend Analytics, leverage the order and invoicing data from your entities, get a deeper and more accurate view on your spend coverage and take relevant decisions based on the most advanced multi-dimensional reports. Thanks to Accelerate Product Management, you can consolidate the information on your products and services and maximize S2C and P2P process efficiency by leveraging the potential of your product database information. Accelerate eSourcing is a state-of-the-art online solution for strategic sourcing that enables you to organize, rationalize and automate every step of the RFx process online, from defining your needs to negotiating online and choosing the right suppliers. Accelerate Contract Lifecycle Management helps you create and maintain a centralized data repository of all the contracts that structure the relationship with your suppliers and help you improve your Procurement compliance.

We create and deliver market-leading solutions to help you optimize investment, unlock value and drive growth. Our end-to-end trading, treasury, risk management and regulatory compliance solutions enable financial institutions to consolidate and streamline their operations. We serve global, central and regional banks, broker-dealers, insurers, asset managers, pension funds, hedge funds, stock exchanges and clearinghouses, securities services providers and corporates. Our targeted solutions and services are powered by exceptional people driving innovation at scale. Risk and regulatory reporting solutions. Meet your immediate regulatory reporting requirements while creating long-term value. Front-to-back solutions for capital markets and treasury. Single source of truth, enabling quicker decision-making and efficient operational processes. You're fighting an uphill battle to manage huge volumes of trades through the transaction life cycle.

Compliance Suite platform is a powerful and dynamic technology solution that assists in the preparation and submission of the Securities and Exchange Commission’s Form N-PORT, Form N-CEN, Form N-MFP, and Form PF, as well as other regulatory filing requirements, such as Annex IV of AIFMD and CFTC, and NFA Form CPO-PQR. It also features robust risk management, performance monitoring, and pipeline and relationship tracking needs of the asset management industry. This intuitive, easyto-use, and scalable solution provides the flexibility that is essential for today’s rapidly evolving business, risk, and regulatory landscape. Compliance Suite’s user-defined architecture allows the system to be extended to other value-added uses beyond the regulatory filing process. Data repository for internal risk management and investor reporting information. Includes user customizable dashboard and fund performance charting functionality.

What if you could bring together all aspects of third party risk into one place? Third Party Tracker, a PwC Product, helps companies screen and manage third parties, identify upfront risks from potential partners, conduct due diligence, and monitor through the lifecycle of the relationship. Address regulatory requirements, meet stakeholder expectations and leverage continuous monitoring to help mitigate financial or reputational risk. Identify areas of upfront risk through due diligence prior to entering into new mergers, acquisitions or strategic partnerships. A web-based solution, no software or plug-ins required. Capture and save reviewer responses to provide historical audit trails. Eliminate back and forth with multi-language capabilities. Stop working in silos and enable your teams to see relationships across the enterprise, resulting in long-term cost efficiencies and enhanced risk coverage.

Talentia Corporate Performance Management (CPM) is a global platform for real time financial reporting, business analysis, budgeting process, forecasting, consolidation & close. Talentia CPM makes information more reliable, increases team productivity and improves decision-making processes. A comprehensive platform to clearly pilot corporate performance: Budgeting, forecasting & rolling forecasting, Management Reporting, Multi-standard Statutory Consolidation, Financial Reporting and Intra-Group Reconciliation. Beneficiate from a complete consolidation and close software allowing multi-standard statutory consolidation, portfolio management and Intragroup reconciliation. From a single repository, analyze performance, reduce delays, make financial communication more reliable and consolidate in compliance with regulatory requirements.

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.