IDEA Regulatory

Exhibitor

Regulatory Affairs Advice, Strategy and Support Services for small-medium biopharma and medtech companies.

Established in 2006 in the UK 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 bespoke regulatory affairs service offering.

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

1. Regulatory Strategy advice and support services including:

•  Scientific/Protocol Advice Procedures
• Orphan Drug Applications, including joint FDA-EMA procedures
•  Regulatory and Medical Writing including Dossier Preparation
•  Development of IMPD's, IB's, PIP's etc.
• Regulatory Submissions

2. 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

3. EU and UK Representation for non-EU/UK sponsors of Clinical Trials and Device Investigations:

•  Legal Representation
• SME Initiative Representation
• Orphan Drug Designation Representation

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