Regulatory Affairs
Our Responsibilities
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.
Services
Sinopep’s dedicated Regulatory Affairs team always carries "customer first" mindset and provides excellent value-adding services through forward-looking gap analyses and meticulous preparation of source documents.
Stages
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R&D
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Registration
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Post-Marketing
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Onsite Inspections
Services
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Strategy and feasibility evaluation during CMC R&D
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Regulatory compliance support during CMC manufacturing
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Technical review for CMC dossiers
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Preparation of bilingual dossiers (including IND, NDA, ANDA, DMF, ASMF, CEP, etc.)
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Dossier filing flow
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Facilitation of partners communication with regulatory agencies
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Monitoring and tracking of review progress
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Change evaluation
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Preparation of annual reports and supplements
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Onsite preparation
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Documents Preparation
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Support for onsite inspections
Experience
Over the years, Sinopep has filed over 100 dossiers to regulatory agencies such as FDA, NMPA, EDQM and PMDA covering ANDA, DMF, CEP and VMF submissions. There has been no delay or failure on deficiency response in any of our filings. Today, our APls and pharmaceutical products have been successfully marketed in over 40 countries.
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100+
Dossiers filed to regulatory agencies
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40+
APIs or pharmaceutical products marketed
Why Sinopep Regulatory Affairs?
Highly skilled and experienced RA team to meet and exceed our partners’ expectation.
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Scientifically sound standard operation procedures to satisfy all technical requirements by various regulatory agencies.
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Globally accepted GMP Manufacturing facilities successfully passed numerous audits by FDA, NMPA, MFDS, etc. to provide confidence and success during onsite inspection for our partners.
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Multi-lingual ability to facilitate direct and effective communication with most of regulatory agencies.
