Regulatory Affairs

Regulatory Affairs Services

Pharmaron’s regulatory affairs (RA) team works closely with partners and our functional divisions to provide global end-to-end RA services, from preclinical through clinical to marketing, including regulatory consultation, integrated drug registration dossier preparation and various regulatory submissions. Our team is experienced with global authority communication, working with partners to obtain fast approvals as well as many other regulatory milestones during the life cycle of your products. The RA team also offers project management, medical translation, training and inspection services.

• Integrated regulatory consultation, project feasibility and strategy evaluation
• Gap analysis to follow the regulatory requirements of different countries and regions, including multinational submission and license in/out programs
• Official communication with authorities for pre-IND, EOP, pre-NDA, etc., including written responses, audio/video meetings, face-to-face meetings and on-site regulatory inspection scheduling
• Drug regulatory submission to China NMPA, US FDA and other regulatory agencies , covering the whole life cycle including IND, NDA/BLA, ANDA, DMF and ASMF, supplementary registration, registration renewal
• Compiling and submission of regulatory packages during the clinical development stage such as DSUR, SUSAR, CMC, non-clinical and clinical amendment
• Regulatory progress and status tracking, covering the life-cycle management of the product
• Trial Master File management
• eCTD validation, publishing, and project life-cycle maintenance
• Orphan Drug Designation (ODD) application and fast approval strategy
• Listing of drug substance and excipient (DMF registration)
• Registration and updating of clinical trials to clinical.gov (China and US)
• Preparation of non-clinical overviews and summaries based on corresponding study reports
• CMC writing covering both small molecules and biopharmaceuticals for IND, NDA/ANDA, BLA; DMF and VDMF authorings (for veterinary drugs) also available