Regulatory

Your Partner in Regulatory Compliance

The regulatory team assigned to your project has access to all information developed through all stages during development and will be in touch with your organization’s regulatory group to ensure that the Chemistry, Manufacturing and Control (CMC) documentation package contains all components requested by the client. Our regulatory team offers ongoing support to your internal department for any documentation submitted in support of your project’s CMC section. Our regulatory teams have assisted our clients with over 100 products resulting in numerous product approvals.

Regulatory Documentation Processes

Regulatory Affairs coordinates the assembly of client products 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 CTC sections.

Regulatory Agencies