The MassBiologics' Quality team is responsible for establishing Quality Assurance Agreements with each client to ensure that regulatory roles and responsibilities are clearly defined to the satisfaction of each party.
Regulatory support and document preparation can be provided as needed in support of our client programs. MassBiologics' Regulatory Affairs department directs and prepares MassBiologics' licensed products and IND submissions for agency approval. Staff will provide regulatory support and assistance in preparing CMC documentation relating to services performed at MassBiologics.
MassBiologics utilizes a validated electronic document management system to host a range of document functions including drafting, review, approval and revision of cGMP documentation, cGMP compliant training records and other processes requiring secure document transactions including role based access control, audit trails and electronic signature. This system can be used to host client documentation and facilitate remote review, approval and FDA compliant electronic signature approval of procedures and cGMP records with individual client access as required.