Regulatory Affairs

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

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 on your project.

As a Project Team Member, Regulatory Affairs has access to all information developed through the client’s project (Phase I 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 Affairs coordinates the assembly of client product and process related documentation suitable for the client’s preparation 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 CTD 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 notification describes changes reported to the FDA.

Regulatory Affairs lead a team of multidisciplinary department representatives that is tasked with evaluating all new products that are presented by our clients. This group ensures that new products and associated processes will meet defined criteria for entry into the facility, without jeopardizing the existing products.

Regulatory Affairs administers the Client Notification System, which is used to inform our clients of changes in the facility, utilities, and processes as well as to notify clients of new products being manufactured. This system is administered as a regulatory service based on the impact a change may have on a client’s application.

Regulatory Affairs is also involved in all regulatory agency inspections, including prior approval inspections for contract products. Regulatory Affairs functions as the liaison for all communications with the regulatory agencies.