The pharmaceutical biotech industry generates massive amount of paper files from clinical studies, New Drug Applications (NDA's), Investigational New Drug (IND's), Disease Diagnostics, Drug Discovery Files, Quality Control Files, CRF-DCF's etc.. Doing business faster, smarter, and easier is a business-intelligence need for the biotech industry. Document retention is one of many keys FDA compliances regulating the pharmaceutical industry. Govitec helps businesses answering compliance and business-intelligence purposes with our eTMF solutions allowing sponsors to by-pass the inherent complexities and inefficiencies that come with paper filing onto an electronic storage medium that incorporates the TMF Reference Model Taxonomy.
Govitec’s focus on process optimization and inspection readiness of the TMF has given us the opportunity to work closely with many of the eTMF solution providers and our industry experts have built a strong technical knowledge-base of the solution ecosystem. From our perspective all the eTMF solution providers have unique features and functions that have the potential to add value to the TMF.
Inquire more about our validated eTMF solution with workflow integration.