We offer a wide range of specialized services for medicinal product licensing, such as:
- Appointed pharmacist services
- Accelerated new product submissions through to approval, regulatory submission file preparation and follow-up and maintenance of the whole regulatory process.
- Licensing renewals, regulatory variation applications, changes to product leaflets and packaging materials.
- Marketing assistance- Preparation and regulatory review of marketed material in line with the requirements of MoH Standard Operating Procedures No. 134 and 137.
- Adverse-events intake and reporting program QPPV (Qualified Person Pharmacovigilance)
- Preparation and approval of packaging materials according to regulatory requirements.
- Promotional material review
- Translations editing