The regulatory teams have assisted our clients with over 100 products for approval
Regulatory Affairs coordinates the assembly of client product and process related documentation suitable for the client’s preparatin of regulatory submissions. Support documentation includes manufacturing process summaries; component, process and personnel flow diagrams, client specific equipment and process validation summaries. Documentation submitted to the client generally contains Master Batch Production Records and batch specific Batch Production Records. Jubilant HollisterStier recognizes that each client has unique needs but ensures consistency in our CMC support through the use of templates that are in alignment with common CTC sections.
U.S. FDA Drug Master File Type V, pertinent to the Small Volume Parenteral Facility, contains a description of the facility, utilities, major equipment and validation summaries of major equipment. The document is on file at the Center for Drug Evaluation and Research, and the Center for Biologics Evaluation and Research, and is updated on an annual basis. Regulatory Affairs will submit letters to either Center as directed by the client. This allows the Center to access the document on behalf of the client. The client is notified annually when the Drug Master File is updated to the FDA. This notificaitn describes changes reported to the FDA.