About Us
Pharma Design Limited is a London-based regulatory affairs and market access consultancy supporting clinical development of innovative therapies. Our customers achieve early access to European Markets by implementing a good strategy from the early stages of clinical development. Our pragmatic and flexible model has made Pharma Design Limited a trusted partner for many pharmaceutical organisations and biotechs seeking entry into European markets. We also support clients with medical writing and ATMP access services.
Our Story
Pharma Design Limited was founded in 2009 by Simon Ruini and a group of clinical, regulatory, market access and safety professionals who wanted to combine their experience across disciplines to create a genuinely integrated service provider.
Fifteen years on, we remain an efficient, senior-led partner to sponsors of pharmaceutical product development worldwide. From CTA applications to MAA submissions and HTA dossier preparation, we support the development of medicinal products for human use across all major therapeutic areas.
Our recent work has included:
- Pioneering ATMP access within early-stage pilot applications offered by EMA as of late 2025
- Helping sponsors secure Marketing Authorisations in Europe across oncology, rare diseases, psychiatry, neurology and other therapeutic areas
- Supporting new drug developers in obtaining CTA approvals across the EU, UK and Switzerland
Our Integrated Approach
We integrate regulatory, clinical and HTA expertise across the development pathway into a single, coordinated submission strategy. Our consultants work with you individually or in small teams, providing senior-level professional input as well as targeted training where needed. For each engagement, we select the optimum skill set and experience from our network of specialists, so you get the right expertise for each phase of your programme.
We support your development from the earliest stages of research. The need for evidence generation ahead of Phase 3 studies, together with long-term resource planning, makes early interaction the rational choice. This shift is also reflected in legislative changes that now require regulatory planning earlier in development. You will not be granted PRIME designation in the EU or ILAP designation in the UK without applying before the start of pivotal Phase 3 studies. Early engagement is no longer an option, it’s a prerequisite for accessing expedited pathways and securing efficient access to European markets.
We specialise in:
Market Research, Meta-analysis, Pricing Dossier, HTA
CTA Submission, Centralised MAA, Scientific Advice, License Maintenance
Benefit/Risk Assessment, PBRER, DSUR, RMP
PV Audit, DDPS, PSMF, PV Inspection preparation
Simply call us to discuss your project needs or send an e-mail, and within 48 hours, we can provide you with advice on the feasibility of your request and our ability to help. We aim to provide an estimate of project costs and a proposal within six working days.
Phone +44(0)755 798 3864 today to speak to our team.