Regulatory Affairs

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TOT BIOPHARM has regulatory affairs offices in both Suzhou Headquarters and Beijing, with a stable team of rich practical experience in drug registration. The team is familiar with laws and regulations, and communication channels and practices of various regulatory agencies. It can provide comprehensive regulatory support service for clients throughout the lifecycle of product development, commercialization, and post-marketing management including regulatory strategy consulting, drug application planning/ project application risk assessment, CMC and / or non-clinical related dossiers writing, etc.

TOT BIOPHARM RA team has extensive experience in drug registration, and has completed over 10 drug applications in China and other countries, including CN & USA IND applications and ANDA/NDA applications.