Affordable, Compliant Content Management & eCTD Publishing When You Need It

Challenge
Consultants, contract research organizations, and small biotech companies have been submitting new drug and biologics applications in paper format. In 2012, FDA released draft guidance that would require that drug and biologic applications be submitted in eCTD format. Migrating from paper format to valid eCTD format, including electronics signatures compliant with 21 CRF11 can be too expensive for early stage biotech’s.

OUR SOLUTION
We are offering a pre-configured, validated system to manage documents electronically that comply with the new eCTD mandate on a per user, per month, subscription basis. This way, you don’t have to invest in an expensive system and dedicated technical staff. You can take advantage of best practices generated by over 100 years of industry consulting experience, and you access the system when you need it.

Qualified & Validated Solutions for Regulatory Submissions!

Basic Capabilities
  • Qualified Microsoft based infrastructure including SharePoint and SQL Server
  • Content management system preconfigured to EDM Reference Model for regulatory submissions
  • Submission-ready PDF renditions
  • Collaborative review and approval workflows

Advanced Capabilities
  • Submission management for IND, NDA, BLA, ANDA and DMFs
  • Optional submission templates for eCTD document authoring
  • Optional eCTD publishing services & software


RegDocs365 is the new turn-key content management solution aimed at helping teams of disparate researchers to prepare their submissions. RegDocs365 is a SharePoint based system implemented on fully qualified infrastructure to host validated applications, including “submission bundles consisting of EDMS & eCTD solutions”, and is purchased on a monthly subscription basis. RegDocs365 enables pharmaceutical, biotechnology and medical device companies to author, review, approve, collaborate, and publish submissions.

RegDocs365 is offered by a consortium of partners with deep life science experience.

e-SubmissionsSolutions.com provides eCTD consulting and publishing services. The system is hosted in Court Square Group facilities located in Marlborough, Massachusetts. The system features a choice of best-of-breed vendors for content management and eCTD publishing and validation.