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
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