IDEA Regulatory


Established in 2006 to provide a specialist Legal Representative service for non-EU clinical trial sponsors. Many of our first clients remain working with us today as we have grown alongside them to fit their evolving needs and developed a complete regulatory affairs service offering. Our expert team works closely with our clients to ensure compliance with all relevant EU and national legislation as it changes.

Our services:
Our services help our clients understand, observe and maximise the regulatory environment, smoothing the path to Marketing Authorisation Approval.

Full Dynamic Regulatory Strategy including all relevant advice and services including:
  • Scientific/Protocol Advice Procedures
  • Orphan Drug Applications, including joint FDA-EMA procedures
  • Regulatory and Medical Writing including Dossier Preparation
  • Development of Investigational Medicinal Product Dossier (IMPD), Investigator’s Brochure (IB), Paediatric Investigation Plan (PIP)
  • Regulatory Submissions Management

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

EU /UK Representation for non-EU/UK sponsors of Clinical Trials:
  • Clinical Trial Legal Representation
  • SME Initiative Representation
  • Orphan Drug Designation Representation