Regulatory Consulting
- Regulatory strategy
- GAP analysis
- Dossier development
- Scientific Advice- Protocol Assistance
Regulatory Applications and Submissions
- Marketing Authorization Applications
- Lifecycle Management
- Marketing Authorization Transfers
- CMC documents preparation (API, FDF)
- EDQM- obtaining CEP
- Clinical Overview and Summary (all legal basis applications)
- Non-clinical Overview and Summary (all legal basis applications)
- Preparation of Module 1-5
- Enviromental Risk Assessment
- SmPC, PIL
Regulatory Operations
- Artwork/Labeling
- Linguistic Review/Translations
- Readability/User testing
- Promotional material preparation
- Price approval procedure for Rx medicines
Medicinal products Pharmacovigilance
QPPV services
Medical writing- Aggregate Reports, RMP and PSMF, PSURs.