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.
Discover our comprehensive range of services
Our specialist services include:
- Quality control (QC) and release testing
- Biosafety and cell and virus characterization
- Microbiology testing
- Packaging and container closure integrity testing
- QC stability testing
- Extractables and leachables testing
Meet biopharmaceutical development and safety requirements
- Design effective CMC strategies
Leverage our expertise to design and implement robust CMC strategies for your biopharmaceutical products.
- Verify product quality and safety
We design testing protocols to verify the safety, identity, purity, potency and function of your products.
- Monitor and control manufacturing processes
Ensure consistent, high-quality products with our comprehensive analytical platforms.
- Accelerate regulatory approval
Speed up your journey to regulatory approval by exploiting our global network of state-of-the-art testing facilities and internationally recognized experts.
Unrivaled CMC expertise and global reach
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.
Noor Tower (2nd, 6th – 10th & 13th Floor),
110, Bir Uttam C R Dutta Road, 1205,
Dhaka, Bangladesh