Regulatory Affairs and Market Access
Regulations are mainly inspired from
- US-FDA Regulations
- EMA Regulations
- WHO Regulations
Registration services are provided for
- Pharmaceuticals
- Cosmetics
- Biosimilar
- Food Supplements
Regulatory Intelligence
- Information obtained through network of local personnel and partners
- Structure and tools adapted to match the evolving regulatory environment
Quality Driven Services
- Inner and Outer Labels Requirements
- Leaflets Requirements
- BE Study Requirements
Quality Driven Services
All services provided with high and consistent quality through controlled and unified procedures for each of the following RA scope:
- Clinical Trials
- Selection and Qualification of Local RA Partners
- Bioequivalence
- Marketing Authorization Import/Export Warehousing
Process Approach
- Regulatory operation is process based
- Processes and procedures reviewed to match regulatory environment changes
Regulatory Services for Import/Export
- Database for import/ export requirements per country
- Local partners to handle the logistics
