Our services

European Representative expertise you can count on 

At IDEA Regulatory we have been partnering with Sponsors, Clinical Research Organisations, and other service providers to fulfil European Representative needs since 2006, with some of our very first clients still working with us today.  

Clinical Study Representation  

• EU Legal Representative for clinical trials and investigations – helping non-EU sponsors comply with the EU Clinical Trial Regulation, Medical Device Regulation and In-vitro Device Regulation 

• UK Legal Representative for clinical trials and investigations – supporting MHRA compliance for UK studies 

• Swiss Domicile for Service and Swiss Importer of Record services – supporting Swiss Medic compliance for studies in Switzerland 

Small and Medium Enterprise Support and Representation 

• Support applying for and maximising the benefits of the European Medicine Agency’s SME Status 

• SME regulatory consultancy service – access to the EMA’s valuable discounts and incentives of the SME Status for non-EU sponsors 

EMA Orphan Drug Designations  

• ODD Representative Service – independent representation for non-EU sponsors developing products for rare diseases. 

UKCA Representative for Medical Devices 

• UKCA Representative Services –  access to the UK market for non-UK Medical Device manufacturers 

Your one-stop solution for regulatory success in pharma, biotech and medtech.  

We help you to navigate the complexities of global regulatory frameworks with confidence. Out expert support spans every stage of the product lifecycle – from early development to marketing authorisation – ensuring compliance clarity and speed.  

Regulatory Strategy Development  

• Customised roadmaps to support your clinical and commercial goals, aligned with global agency expectations.  

PRIME: Priority Medicines for Breakthrough Therapies  

• Expert navigation of accelerated programmes such as EMA PRIME, MHRA ILAP, and FDA Fast Track – from eligibility through to agency engagement.  

Scientific Advice Procedures  

• Comprehensive support for Scientific Advice with the EMA, MHRA and national agencies – including briefing document preparation, meeting support and follow-up strategy.  

Paediatric Investigation Plans  

• Drafting, submission and negotiation of Paediatric Investigation Plans, including waiver/deferral strategies across Europe and the UK.  

Quality and CMC Expertise  

• End-to-end Chemistry Manufacturing and Controls (CMC) support – from development-phase planning to Module 3 preparation and post-approval change management. 

Dossier Development and Submission Management  

• Preparation, review and submission of robust regulatory dossiers (eCTD/NeeS), ensuring accuracy, alignment and agency-readiness.

Regulatory On Call

• Answers to your ad hoc regulatory questions at the end of the phone or by email
• Quick turnaround regulatory advice & consultancy as and when required
• Managed via a monthly retainer fee