Chemistry, Manufacturing and Controls (CMC)
A very vital part of the clinical trial or marketing application is the CMC (Chemistry, Manufacturing and Control). In order to ensure your program progresses as scheduled, you need specialized regulatory and technical guidance and support during the drug substance and drug product development processes. At VCLS, we understand how to anticipate and overcome potential difficulties in the development of chemical entities, biologicals and complex biologics including cell and gene therapy. We can help you reach your next milestone by providing scientific and regulatory expertise in all areas of CMC development.
Bridging Technical and Regulatory Expertise
Our CMC experts in the US and EU have the ability to cover a global CMC development to cover requirements from both the FDA and European Heath Authorities. They address the various regulatory and technical aspects of CMC in a pragmatic manner adapted to your product complexity and taking into consideration the stage of your development as well as the evolving quality and regulatory environment. They have proven ability to navigate at the interface of regulatory, scientific and technical challenges while keeping close interactions with regulatory agencies and experts.
We know that innovation is often driven by small to medium size companies therefore, we provide services adapted to your available budget and timelines with prompt reactivity and flexibility as a high-quality extension to your team.
- CMC strategic development
- Agency meeting preparation
- BLA/NDA/IND/IMPD/DMP preparation
- Responses to Agency Questions
- Adaptation EU/US
- Post-approval maintenance and LCM
- GMP requirements
- Due Diligence
CMC Technical Advisory
- Manufacturing and Quality
- Analytical Method Development/Validation
- Potency Assay strategy
- Release and Stability testing, Specifications
- Process Development and Validation, QbD
- Identification of CMO, Technology Transfer and Comparability