Sinopep's Regulatory Affairs (RA) team works closely with all relevant functional organizations to provide global end-to-end RA services to our partners, from pre-clinical and clinical studies to product launches, including regulatory strategy consulting, technical review, dossier preparation and submission, as well as communication with regulatory agencies. The core RA team members have at least 15 years of drug registration experience, are familiar with the regulations and technical requirements of FDA, NMPA, EDQM, PMDA, etc.

Our well-trained RA staff are very familiar with different electronic submission systems in various countries and regions.