We give the following services with my partners and team mates
- GAP Analysis
- Regulatory Strategy consultation and management
- Scientific Advice and agency consultation management
- GMP auditing – prior to agency certification inspection
- Market Authorization Holding (for registration purposes)
- Market Authorization Application management
- CP, DCP, MRP, RUP, National Procedure
- Full Life-Cycle Management – Renewals and Variations
- Local requirement compliance and representation
- Agency assessment intervention/negotiation
- Readability Testing
- eCTD life cycle maintenance
- Translations
- QPPV & Local Safety Contact Services
- Pharmacovigilance services
- Business Development services like finding niche products for companies, giving the GAP analysis and P&L analysis, informing about the tendency, connecting with right contacts.