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Regulatory
- Regulatory Affairs prepares and supplies a complete range of regulatory documents suitable for the client’s regulatory submissions (U.S. and international). Documentation includes facility description and systems, manufacturing process summaries, component, process, and personnel flow diagrams, client-specific equipment and process validation summaries, Master Batch Production Records, and batch specific Batch Production Records. It is recognized that each client has unique Chemistry, Manufacturing and Control (CMC) needs.
- Regulatory Affairs has access to all information developed through the client’s project and is in touch with the client’s regulatory group to ensure that the CMC documentation package contains the appropriate information. Regulatory Affairs offers ongoing support to the client’s regulatory department for any documentation submitted in support of the client’s CMC Section.
- Regulatory Affairs can provide letters of authorization to our U.S. FDA Drug Master File Type V, pertinent to the Small Volume Parenteral Facility. This master file 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 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 allowing the Center to access the document on behalf of the client.
- Regulatory Affairs is also responsible for administering the online client notification system, which is used to notify our clients of changes in the facility, supporting utilities and process changes. This includes the addition of new products to the facility.
- Formulate Regulatory Strategy
- Prepare and Supply a Complete Range of Regulatory Documents (BLA, NDA, MAA, CTD, LoA)
- Provide Guidance and Expert Review of Regulatory Submissions
- Facilitate Effective Interaction with Regulatory Authorities
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