We will provide our valued customers with analytical chemistry research and quality control services for NCEs throughout their life cycle from early clinical stage to commercial manufacturing.
Guided by Quality by Design (QbD) we provide comprehensive analytical method development and validation in accordance with ICH Q2 based on Critical Quality Attributes (CQA) to support oral dosage form development. We also perform life cycle management to ensure quality research and control provide accurate and reliable data at different drug development stages.
In addition to routine analysis, we support in vitro dissolution method development for insoluble compounds, e.g. amorphous solid dispersion, by understanding the fundamentals of dissolution mechanism, and providing in vitro dissolution data to build the IVIVC research. We also provide genotoxic impurities, elemental impurities, and microbial limit testing services.
CFS provide analytical services by strictly following the cGMP regulations of NMPA, FDA, and EMA, as well as Technical and Quality Agreement (TQA) with our customers. We test and release drug products according to these quality standards to meet the regulatory requirements of countries and regions where clinical supplies and commercial products are distributed.
Stabilities studies, regardless of preformulation, early, or late stage developments, are critical for formulation development. CFS provide stability services at each development stages, including protocol design and testing of accelerated stability studies for preform and prototype development, probe and IND stability for RED at early development stages, stability study at late stage, e.g. Product Characterization Study (PCS), Formal Stability Study (FSS), for packaging definition, stability of intermediates (e.g. Spray Dried Intermediates, SDI), the hold-time stability of the drug products in production, in-use stability testing , stability of storage conditions and photostability testing based on ICH Q1A/Q1B, reevaluation of stability beyond the expiry date, and stability study of drug products after commercial launch etc. These stability data provide strong evidence for packaging selection, expiration date setting, and lifecycle stability evaluation of drug products.
Excipients play an important role in drug release, drug stability and manufacture of drug product. CFS help customers select the appropriate excipients in early formulation development through our comprehensive understanding of molecule and material properties. Analytical science supports the formulation composition design by investigating the interactions between API and excipients.
We also provide compatibility study between packaging components and drug products, helping our customers choose appropriate packaging materials and evaluate the risk through well-designed extractable and leachable studies.
CFS provide release testing service for API, excipients and packaging components according to the regulatory and GMP requirement at different development stages, ensuring product quality and safety by controlling from the original source.