e-Submissions Solutions

The Adlib-RegDocs365 partnership leverages each organization’s focus and expertise in delivering solutions to the life science compliance and regulatory submissions arena.

RegDocs365 helps small or virtual companies who do not have the personnel, facilities or budget to create and manage regulatory submissions and clinical trial content in-house. It is a SharePoint-based content management solution offered on a per-user monthly subscription, deployed in a “Qualified Cloud Environment”.

Configurations are available for the EDM Reference Model for Regulatory Submissions and electronic Trial Master File (eTMF).

How it Works

Adlib is a core component within the RegDocs365 solution, automating the conversion of documents to ensure compliance with global health authorities’ requirements for PDF files in regulatory submissions. Adlib PDF Enterprise assures that all PDF files supplied by clients are compliant with health authority specifications.

About RegDocs

RegDocs365 is the new turn-key content management solution aimed at helping teams of disparate researchers and medical writers to prepare their submissions. RegDocs365 is a SharePoint based system implemented on a 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.

For more information about Adlib PDF for Life Sciences, click here to learn more.

Additional Information

Name of Primary Product(s)/Service(s): RegDocs365

References & Resources:
About RegDocs:

Reach: Global

Industry Focus: Life Sciences