Pharmaceuticals | Medical Devices | Life Sciences
Regulatory Affairs Services:
- Regulatory strategy & compliance (EU, MENA, Global)
- Medical device classification & MDR readiness
- CE Marking, technical documentation, PMS
- CTD/eCTD preparation and submissions
- API supplier evaluations (DMF, CEP, GMP)
- Audit readiness & gap analysis
- Business development strategy & support
Business Development Services:
- Regulatory strategy & compliance (EU, MENA, Global)
- Medical device classification & MDR readiness
- CE Marking, technical documentation, PMS
- CTD/eCTD preparation and submissions
- API supplier evaluations (DMF, CEP, GMP)
- Audit readiness & gap analysis
- Business development strategy & support
Training Course:
- EU MDR & ISO 13485 Compliance
- CTD/eCTD Technical Writing
- Regulatory Affairs for Beginners
- MENA Regulatory Landscape
- Evaluating API Supplier Files
- Regulatory-Business Alignment
- Email Etiquette for RA Professionals