Deploying a robust chemistry, manufacturing and control (CMC) strategy is critical to the successful regulatory filing of a biologics license application (BLA). The complexity of biopharmaceuticals, including peptides, proteins, oligonucleotides and cell-based therapies, requires precise and comprehensive CMC testing.
Our extensive laboratory network and expertise provide design and execution of testing protocols that verify product safety, identity, purity, potency and function. Our services ensure consistent, high-quality products and include method development, validation, stability testing and container closure assessments, supporting your journey to regulatory approval efficiently and cost-effectively.
Search within Chemistry, Manufacturing and Control (CMC) Quality Control Testing
Our specialist services include:
Leverage our expertise to design and implement robust CMC strategies for your biopharmaceutical products.
We design testing protocols to verify the safety, identity, purity, potency and function of your products.
Ensure consistent, high-quality products with our comprehensive analytical platforms.
Speed up your journey to regulatory approval by exploiting our global network of state-of-the-art testing facilities and internationally recognized experts.
As a global leader in inspection, certification and testing, we provide unmatched expertise in CMC quality control testing for biopharmaceuticals. Our dedicated professionals partner with you from the early stages of method development through to refinement and validation. With a global network of specialist testing facilities, our highly experienced scientists and consultants deliver fast, cost-effective, and high-quality analytical support tailored to your specific needs. We operate within international quality standards to deliver accurate data that supports your CMC programs, regardless of complexity and location.
