Market Access, Regulatory and Clinical Trial Experts in Europe
Pharma Design is a small service provider with a network of specialised consultants.
Core Services
- Strategic and Regulatory advice
- Marketing Applications, Scientific Advice, Paediatric Advice
- Orphan Designation
- Paediatric Plan and PDCO interaction
- Clinical Trial Design and CTA submission (EU, UK, Switzerland, Israel)
- Clinical Safety & Pharmacovigilance (DSUR, PSUR, RMP submission)
- Establishment of European subsidiaries, legal entities, headquarters, management teams
Our Services Are Highly Competitive
Pharmacovigilance
Our PV services covering your products in Europe, including EU, UK, Switzerland.
Regulatory Consulting
Choose our Regulatory Affairs strategic services for your products or have our specialised consultants outsourced to your team.
Market Access
Let us help you establish legal entity in Europe and prepare for Market Launch.
Recent Articles
-
IHSI’s role and HTA in the EU
Here is the clarification of IHSI’s role, its relationship to the EU institutions, and your obligations as a company. 1. What is IHSI? (The Legal…
-
Navigating ATMP Marketing Authorisation Applications in Europe
As specialists in regulatory affairs for pharmaceutical developers, particularly those outside the EU, Pharma Design Limited has extensive experience guiding clients through the complexities of…
News and Updates
-
The MHRA-NICE Accelerated Aligned Pathway Pilot.
The Medicines and Healthcare products Regulatory Agency (MHRA) and the National Institute for Health and Care Excellence (NICE) have launched the Accelerated Aligned Pathway pilot,…