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: