Services
Our experience combines a technical vision in the Regulatory area with a transversal business vision, both in the pharmaceutical industry and in the professional consulting services.
Pharma Industry:
- Regulatory Strategy Definition
- Management of Regulatory Dossiers for New Medicinal Products Submissions and Variations
- Guidance on Early Access Programs
- Promotional & Educational Materials Review
- Compliance Expertise
- SEVEM management (EMVS; NMVS; NMVO; EMVO)
- EUDAMED registration
- Interaction with Regulatory Authorities, both Local and Regional
- Advise in pharmaceutical legislation
- Clinical Trials Submissions
- Preparation of new SOPs/local procedures
- Support in the national establishment of foreign companies
- Scientific texts and Product Information translations, including QRD
- Support Activities in Market Access
Medical Devices Companies:
- Request of Import and Distribution Licenses of Medical Devices
- Medical Devices Dossier Submissions to the AEMPS
- Advise in medical devices legislation
- Interaction with Regulatory Authorities, both Local and Regional
What can Best Pharma Consulting do for your business?
Contact us for information and direct advice
