We’ve worked with numerous companies to process their submissions to the regulatory authorities. Seeing a common need, we decided to take the environment we had and create something that small to mid-size companies could use for their eCTD needs.
Think Outside of the (Drop)Box
Many of our customers come to us with pieced-together solutions that are not compliant. They have documents and filing deadlines held in uncontrolled BOX or DropBox environments. By migrating their documents into our DIA EDM or eTMF reference model libraries, we provide the appropriate metadata and the PDF Rendering provided by the Adlib Enterprise PDF Rendering engine. The result is submission-ready content in a repository where our clients and work with external collaborators.
Full Version Control and 21 CFR Part 11 Compliance
Many of these companies have external medical writers or MS Word experts that can format the documents so that they pass the rigorous needs of the FDA or other regulatory bodies. We can establish the content repositories for multiple drug products with numerous clinical sites and have all of the metadata automatically applied as the data is migrated in. We have full version control and auditing needed for 21 CFR Part 11 compliance and we can incorporate numerous methods of electronic signatures based on the companies requirements.