Audience
Pharmaceutical companies wanting a full-featured eCTD management solution to ensure fast and secure data transfer
About BeeCTD
BeeCTD is a full-featured eCTD management solution for pharmaceutical companies and regulatory agencies. Modular architecture and transparent licensing policy allow our users to choose from modules which they want to use – Reader, Compiler, Validator. Full-featured Reader which helps you to get an overview of the entire lifecycle of the dossier containing eCTD and/or NeeS sequences, including baseline submissions while transferring from NeeS to eCTD. Realtime, fast sequence validator fully compliant with eCTD / NeeS technical specification, incl. best practices criteria. The latest version of eCTD validation criteria is always updated, older versions are available. Get your documents compiled into the eCTD-compliant format. Use our eCTD compiler tool as a product, which allows you to compile yourself or as a service - we compile for you on demand.
Other Popular Alternatives & Related Software
LifeSphere RIMS
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.
Learn more
RegDocs Connect
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
Learn more
Kivo
Kivo is a better way to work for sponsors and CROs, offering an affordable document and process management system that helps life sciences teams get work done in one intuitive, compliant workspace. It brings DMS, RIM, QMS, eTMF, and eCTD capabilities together so pharmaceutical, biotech, medical device, and biologics teams can manage regulated documents, quality activities, clinical trial files, regulatory submissions, and process workflows without disconnected tools. Kivo’s Document Management System provides one place for controlled documents, process automation, project management, corporate documents, and diligence readiness, with centralized storage, version control, collaboration, audit trails, search, workflow automation, and Part 11-compliant e-signatures. Its RIM system supports correspondence, project management, submission building, publishing handoff, eCTD viewing, dossier management, agency interactions, health authority commitments, etc.
Learn more
GlobalSubmit
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.
Learn more
Integrations
No integrations listed.
Company Information
Altamira
Founded: 2009
Slovakia
www.altamira.ai/beectd/
Videos and Screen Captures
Other Useful Business Software
Ship Agents Faster
Gemini Enterprise Agent Platform lets you rapidly build, scale, govern and optimize production-ready agents grounded in your organization's data. The platform enables developers to build custom or pre-built agents for virtually any use case. New customers get $300 in free credits.
Product Details
Platforms Supported
Cloud
Support
Phone Support
Online
