Market Access, Regulatory and Clinical Trial Experts in Europe

Pharma Design is a small service provider with a network of specialised consultants.

 

We assist Pharmaceutical Companies & Biotechs in achieving Marketing Authorisations in Europe and preparing adequately for Market launch.

We represent Companies headquartered outside of the E.U. taking care of all their regulatory duties. Finally we provide assistance with Safety and Quality of operations during development and post-marketing.

  • Strategic and Regulatory advice
  • Marketing Applications, Scientific Advice, Paediatric Advice
  • Orphan Designation
  • Market Access, HTA and Price Analyses
  • Clinical Trial Design and CTA submission
  • Clinical Safety & Pharmacovigilance
  • Establishment of European subsidiaries, headquarters, management teams

Pharma Design is integrated into the EMA and National Regulatory Authorities and is positioned to ensure that clients comply with all local laws and regulations.

Working with Pharma Design allows client companies to make an immediate strategic impact in Europe and avoid the pitfalls and mistakes that are often made during a learning process. Using our well-established outsourcing model ensures flexibility of approach from large-scale development projects, to discrete ‘modular’ technical reports or client-managed interim expertise on the ground, in Europe.

Recent Articles

Concept paper on the revision of ‘First-in-Human’ Guideline clinical trials

EMA has just released a concept paper to revise the First-in-Human Guideline and is requesting comments to address the need for updated and more streamlined…
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News

Can you apply for a Centralised Marketing Authorisation in Europe ?

Medicinal products falling within the mandatory scope of the Annex of Regulation (EC) are obliged to apply for a Centralised Procedure: Recombinant DNA technology-Controlled expression…
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