Product Registration

       Application for Clinical Approval: CTA, BLA, BE and MRCTs

       Application for Market Approval: NDA, ANDA

      DMF Filing for APIs, Pharmaceutical Excipients and Packaging Materials

       Supplementary Application/Re-registration

 Registration Strategy

       Registration Feasibility Assessment

       Registration Pathway, Strategy and Risk Assessment

       Registration and Regulation Consulting

 Customized Training

       Regulatory Affairs Guidance and Best Pathways to China

       Product Registration (NDAs, ANDAs & MA + MAH)

       Drug Master File (DMF) Filing

       GMP Compliance and Certification

       Post-market Regulatory Supervision of Drugs

 Pharmaceutical & Medical Translation Service



       Pharmacology and Toxicology Reports

       Clinical Trials


       Labels, Package Insert and Journals

 Local Agency Support

       Registration Application & DMF Filing

       Applications of Change

       Regulatory Communication with Local Authorities

       Compile, Editing and Submission of Annual Reports


       Development of Safety and Risk Management Plans

       Data Collection,Entry and Evaluation

       Follow Up of Safety cases

       Preparation and Submission of Safety Report

       Literature Retrieval at Home and Abroad

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