Regulatory Affairs services (薬事):
- Registration of: pharmaceutical products, biological drugs, OTC, medical devices, cosmetic, biocides, disinfectants, food supplements, radioactive.
- Appointed pharmacist and Responsible Pharmacist – Qualified Person (QP) services
- Qualified Person Pharmacovigilance (QP-PV) services
- Named Patient Supplies handling
- Marketing Authorization Holder (MAH) services
- Leveraging regulatory time and shortening time to market with your preferred partner
- Drug Safety Scan – International monitoring of Drug Safety Reports
- Risk Management Plans
- Strategic Intellectual property (IP) protection tools and strategies
- Quality systems auditing (certified auditor)
- Reimbursement, Health basket submission, pharmacoeconomic models
- Negotiations with the competent authority
- Regulatory newsletter
- Regulatory affairs and Quality training
- Reports, evaluation and implication analysis of new legislation
- Strategy Workshops
Need more information? Contact us here.
Mind Pharma provides Appointed Pharmacist , Responsible Pharmacist – Qualified Person (QP) & batch release , Qualified Person Pharmacovigilance (QP-PV) , Market access and Market Insight support and Medical Director services.
We also support establishing quality assurance system management, writing SOPs, audits, mock audits, quality and technical agreements.