GAMP5 Annex 11 21 CFR Part 11
Chemistry, Manufacturing & Control
Full life cycle
CMC is an acronym for chemistry, manufacturing, and controls, an FDA term used globally to describe the data for the manufacture and testing of a medicinal product. This term has now been replaced by Pharmaceutical Quality/CMC, which are crucial activities when developing new pharmaceutical products. CMC involves defining manufacturing practices and product specifications that must be followed and met in order to ensure product safety and consistency between batches.
With a science-first approach to understanding your product, combined with first-hand insights of regulatory expectations and requirements, help support the successful design of your CMC plan — including process and formulation development, analytical development identifying Critical Quality Attributes (CQA) and Critical Process Parameters (CPP), developing control strategies, establishing quality testing methods and reviewing validation protocols and reports
Working with Tiffany Rau, who is experienced in regulatory strategy and CMC development will help you analyze and document the manufacturing processes, active substance and drug product characteristics, and testing to ensure the product is safe, effective, and consistent.
From early-stage development and at every point through commercialization, BPTC partners with you to tackle complex CMC development challenges. We ensure the regulatory authorities see the control and robustness of your process and product from a documentational and operational perspective. As your CMC consulting partner, we can smooth the path to marketing authorization application (MAA)/new drug application (NDA) approval and commercialization, balancing cost, risk, and speed to help you ensure quality manufacturing and effective controls for the health and safety of patients.
Supplier and Internal Audits
Process Development
Scale-up and Scale down Models
Design for Manufacturability
Process Charactorisation
Bioreactor Development
CMC
Facility Design & Startup
Regulatory Compliance
Biotech consultancy with expertise in CMC, Cell and Gene Therapy, Process Development and Commercialisation, Compliance and Tech Transfer
