Ensuring Quality from Concept to Regulatory Submission
CMC, chemistry, manufacturing, and control is required throughout the drug development and manufacturing process for any pharmaceutical or biologic. Specific manufacturing processes, product characteristics and product testing must be defined in order to ensure that a drug product is safe and effective and ensures batch consistency. It is important to note that CMC requirements vary for different products, including small molecules, large molecules and gene therapy products. Working with an end-to-end solutions provider is vital to ensure that specific requirements are met throughout the entire process. Our experts not only understand the process from the initial research stage, but also are savvy with various regulatory requirements for specific products.
From Preclinical to Manufacturing
- Preclinical: Proper analytical methods are validated to monitor the products, stability testing can be initiated, physicochemical properties are determined, raw materials are selected and tested
- Clinical: Continued analytical method validation is required, additional characterization of the drug is also required
- Scale Up: Ensure that larger batches or the product are the same and meet the same specifications as clinical trials
- Manufacturing: Qualification, lot release and process testing continued
Our Edge in CMC and GMP Analytical Services
CMIC’s experience for CMC and GMP analytical services includes many achievements from authorities, a proven track record of numerous GMP release tests ranging from physicochemical analysis, microbiological testing and analysis of biopharmaceuticals.
- Providing Various Analytical Methods
- Comprehensive Service Offerings from Pre-formulation to Commercial Products
Full service solutions from analyzing and evaluating the quality of drugs from pre-formulation to commercial products. Our GMP analytical services include measurement techniques with biopharmaceuticals, regenerative medicine, narcotics, psychotropic and high potency APIs (chemical hazard substances). - FDA Approved Quality
Our GMP analytical services are carried out in laboratories with FDA inspection experience.