IDEA Regulatory
Exhibitor
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:
Regulatory On Call:
EU /UK Representation for non-EU/UK sponsors of Clinical Trials:
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
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