Regulatory Consulting for Orphan Drugs
Aptiv Solutions regulatory experts have significant experience in gaining regulatory approval for the development and marketing of Orphan Drugs in Europe, US and Japan. This expertise covers:
Orphan Drug Regulatory Consultant Expertise:
- Medical and regulatory review of potential indications
- Orphan Drug Designation
- Scientific Advice/Protocol Assistance
- Orphan Medicinal Product Application pre-submission meetings
Importantly, regulatory agencies advocate the use of Adaptive Clinical Trials for the development of orphan drugs and Aptiv Solutions regulatory team, in conjunction with its adaptive design experts, can assist sponsor companies in the design and implementation of clinical studies in a wide variety of orphan indications
