Service

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 Feasibility Assessment

Registration Pathway, Strategy and Risk Assessment

Registration and Regulation Consulting

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

Dossiers

Pharmacology and Toxicology Reports

Clinical Trials

Labels, Package Insert and Journals

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