We have a proven track record in providing innovative and cost effective support in all aspects of regulatory work to our partners.
We also have an ability to deliver bespoke regulatory solutions to meet all clients’ requirements:
- Management of all EU procedures (MAA & CTA).
- New drug applications for generic, herbals, biotech and traditional medicinal products.
- Advice on filing strategy.
- Risk assessment for product development plans.
- Expertise in multiple therapy areas.
- Maintenance activities and record management.
- Due Diligence.
- Regulatory Intelligence.
- Submission writing, compilation and publishing.
- Regulatory Training.