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