Regulatory Affairs – CMC

REGULATORY AFFAIRS-CMC

Chemistry, Manufacturing, and Controls (CMC) is an essential and complex part of pharmaceutical regulatory submissions and it is intricately connected to GMPs. CMC regulatory requirements vary across different stages of development/product lifecycle, and certain requirements are specific of product type.

We assist our clients to focus on regulatory submission requirements specific to their biopharmaceutical products, including:

Identifying regulatory priorities and supporting the design of your products’ regulatory strategy.

Preparation and gap analysis of the CMC sections of Investigational New Drug (IND) applications. 

Preparation and gap analysis of CMC sections of Biologic License Applications (BLAs) including all quality assessment disciplines (comparability assessment, analytical evaluation, microbiology product quality and sterility assurance). 

Preparation of regulatory dossiers towards formal regulatory meetings and assistance with other types of formal communication with regulatory agencies.

Develop business solutions to address specific client needs using expertise, knowledge of the client’s business model and industry best practices.