EU Protocol Advice (PA) procedure

Challenge

• To obtain EU PA on behalf of a small US-based speciality company focused on developing medicines for rare diseases
• The prodcuts were classed as ATMPs and were gene therapy for inherited neurological and metabolic syndrome disorders

Solution

• Real Regulatory planned, prepared for, attended, and conducted follow up for an EMA PA procedure
• Other activities for the same client included ATMP classification; authoring, submission and maintenance of ODD; preparation and submission of PIP application to EMA

Result

• Procedure completed and advice issued