Pharma Design is a small service provider with a network of specialised consultants.
Strong Oncology expertise including BiTes, T-Cells and Mabs
We assist Pharmaceutical Companies & Biotechs in achieving Marketing Authorisations in Europe, UK and Switzerland.
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
- Paediatric Plan and PDCO interaction
- Clinical Trial Design and CTA submission
- Clinical Safety & Pharmacovigilance
- Establishment of European subsidiaries, headquarters, management teams
Pharma Design has contributed to the licensing of new chemical entities, monoclonal antibodies, BiTes and T-Cells with EMA 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 Euro pe.
