Sinopep provides one-stop CRO services based on our deep understanding of ICH and our research and development philosophy of QbD. With professional knowledge and strict standards, we provide customers with pharmaceutical research, clinical services and registration services of (chemical, peptide) drugs to meet the needs of customers at different stages of consistency evaluation and clinical bioequivalence of generic drugs.
API research: develop manufacturing process, synthesis impurities or other chemical compounds, screen polymorph and optimize crystallization process, complete from pilot to commercial.
Formulation research: prescription develop, RLD analysis, DoE design, complete from pilot to commercial.
Quality Research: design the protocol of quality control, develop and validate the MOA, standardize impurity reference, study element impurity, identify and control genotoxic??????? strategy, etc.
Clinical study services
Preparation stage: Find the experts and centersfor executing study, finish ethic issues declaration and clinical study registration.
Executing stage: Recruit, screen and interviewthe subjects, follow up inspection and monitoring, reserve material and biospecimen.
Project management: communicate with experts, sponsors, ethical institutions, analysis and testing center,assist experts finishing reports, handle inspection issues, make sure the study canbe finished successfully as scheduled.
Registration services: evaluate the feasibility of projects, review and revise all documents, file and submit CTD format DMF, handle sample testing and specification establishing, answer observations till approved.