Services

Our services

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.  

Small and Medium Enterprise (SME) Incentives  

Support for securing Small and Medium Enterprise (SME) status with the EMA – enabling access to feed reductions and regulatory incentives.  

Orphan Drug Designation (ODD)  

Strategic planning and full support for EU/US ODD applications, including eligibility assessment justification writing.   

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

From reach out to project set up, through periodic updates the whole process went very smoothly. Our communications with the team were proportionate, appropriate and helpful. We would definitely use them again should the need arise.

I have used IDEA Regulatory for more than a decade for EU legal representation services. Quite simply, I cannot imagine working with anyone else. They are highly competent, extra dedicated and the team comprises those rare individuals that simply have the ability to improve your day!

What I love, is that you never have to wonder. The appropriate information is there. They back everything up with up-to-date guidance to hand if needed. I also feel they have been great mentors in this space. I have learned so much from them.

The set up and contract negotiations were smooth and easy and communication was regular and proportionate. I have since used IDEA Regulatory again on another trial and will continue to do so on the back of this positive experience.

Program Manager

Rare Diseases biotech company

Manager

Regulatory Affairs Operations,
Drug Discovery and Development Company

Manager

Rare Diseases Drug Discovery and Development Company

Associate Director Clinical Trials

Oncology Biotechnology Company