Ensuring Product Quality for Patient Health and Safety
Well before you’re ready to test your medicinal product on humans, you must develop a chemistry, manufacturing, and controls (CMC) process to ensure quality manufacturing standards have been established. This information is required in Module 3 of the clinical trials application (CTA), such as the investigational medicinal product dossier (IMPD) in Europe and the Food and Drug Administration’s (FDA’s) investigational new drug (IND) application in the US, as well as EU marketing authorization applications, FDA new drug applications (NDAs) or biologics license applications (BLAs). The primary objective of CMC is to assure the quality of the finished product during all phases of development. Regulatory authorities need to see detailed standards to ensure consistency of identity, safety, quality, stability, and strength between the product used for clinical trials and product batches produced for commercial purposes on an ongoing basis.
All companies with investigational products are required to follow the specific details of their CMC for every phase of the product lifecycle, including lifecycle management activities, eg, technology transfer and line extensions. A critical element is knowing which steps and variables in the manufacturing process need to be controlled and why in order to obtain a comprehensive understanding of the manufacturing process and the necessary control strategy. Working with a global partner experienced in regulatory strategy and CMC development can help you appropriately 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, ProPharma Group partners with our clients to tackle complex CMC challenges. We help ensure the regulatory authorities see the control and robustness of your process and product from a documentational and operational perspective. As your CMC 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.
Science-Focused Regulatory CMC Experts
At ProPharma Group, our regulatory experts are scientists first and foremost. Our team of PhDs and MDs have decades of global regulatory and quality experience, allowing us to provide a unique level of service:
- Our unmatched global reach means we can work with you to prepare your marketing applications (MAA or NDA) in parallel, saving you time and money
- Our 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
- Our 30+ years of providing regulatory affairs services means we’ve seen how submission requirements and expectations are constantly evolving. Our frequent contact and extensive experience with regulatory agencies ensure you will be following the latest FDA and European Medicines Agency (EMA)/national agencies guidance
- Our understanding of the regulatory world means that we can interpret the regulatory landscape and translate this into a successful regulatory CMC strategy. We can also provide scientific advice and prepare, coordinate, and participate in meetings with the regulators of interest
- Our unique standing as a single-source provider of regulatory, life science consulting (including quality assurance), pharmacovigilance, and medical information services offers you a cohesive, multidisciplinary extension of your team through every phase of the product lifecycle