Support Services

Regulatory Affairs

One of the most demanding aspects of any pharmaceutical development project is working with the various regulatory services.

The Jubilant HollisterStier Regulatory Affairs Department is experienced in working with U.S. and International regulatory agencies and is ready to put this experience to work for your project.

Regulatory Affairs has access to all information developed through the client’s project (Phase 1 through Commercial) and is in touch with the client’s Regulatory Group to ensure that the Chemistry, Manufacturing and Control (CMC) documentation package contains all components requested by the client. Regulatory Affairs will offer ongoing support to the client’s Regulatory Department for any documentation submitted in support of the client’s CMC section. The Jubilant HollisterStier Regulatory teams have assisted our clients with over 100 products resulting in numerous product approvals.

Regulatory Agency Spokane,
USA
Montreal,
Canada
USFDA
EMEA
Japan PMDA  
UK MHRA
Brazil ANVISA
Health Canada
Kenya Health Authority
MAH Turkey
Australia TGA
South Korea

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.

 

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