CMC Services

Our Services

Our team comprises seasoned professionals with deep knowledge of regulatory requirements, manufacturing processes, and quality control measures, and they have backgrounds in chemistry, biotechnology, pharmaceuticals, and regulatory affairs. This interdisciplinary expertise allows us to address complex CMC challenges with innovative solutions. Moreover, we have extensive experience dealing with various regulatory agencies worldwide and are familiar with different regulatory frameworks ensures that we can help our customers meet global requirements with ease. With these, our company provides comprehensive CMC services.

• Strategic Planning and Development: We provide strategic guidance during the early stages of product development to ensure that your CMC strategy aligns with your overall business goals. In addition, we assist in the design and implementation of CMC activities that are efficient, cost-effective, and compliant.
• Regulatory Documentation: Our team assists in preparing reviewing and maintaining your regulatory documents for all pre- and post-approval submissions (small and large molecules) - including drug master files, investigational new drug applications, Biologics License Application, new drug applications and marketing authorisation applications - for the United States, Canada, Europe and other regions.
• Process Development and Optimization: Our experts assist in developing and optimizing manufacturing processes, including drug substance process development and drug product formulation & process development, ensuring scalability and reproducibility and enhancing the overall quality and safety of the pharmaceutical product.
• Quality Control and Assurance: We provide thorough quality control and assurance technical guidance, including the development of analytical methods, stability testing, and validation.
• Others: We also provide support for CMC gap analysis, general CMC consultancy on topics such as agency meetings, response to Complete Response Letters, and post-approval maintenance, etc.