One-stop drug development
Drug substance development
Drug product development
Quality consistency evaluation of generic drugs
SoliPharma develops solid orals, injectables and topical dosages for USFDA and China NMPA approval.
Our full-range R&D service assists pharmaceutical companies from early stage strategic planning to product development until commercialization.
Our effective management of BE and clinical studies with domestic and oversea CROs offer reliable in-vivo study results to support drug development and submission.
Our Regulatory Affairs team communicate frequently with the U.S. FDA and NMPA to ensure accurate and up-to-date information.
Our excellent record in GMP, safety, and environmental compliance allows flawless agency inspection.
USFDA GMP consulting
Intellectual property services
Polymorph patents are one of core intellectual properties of pharmaceutical substances. The rational mapping of crystal-related intellectual property is an important strategy for maxium extension of the drug life span. Solipharma provides IP-related advices and technical support to pharmaceutical companies.