Medical and Clinical
Medical and Clinical
Led by a board certified Medical Director, PharmaAS provides the clinical depth required to bridge the gap between scientific research and regulatory approval.
Clinical Trial Support
- Regulatory Submissions: Full support for clinical trial applications, scientific advice and other regulatory agency interactions.
- Protocol Design: Focused on scientific integrity and medical safety oversight to ensure validity in line with ICH-GCP.
Medical Governance & Safety
- Expert Statements: Creation of authoritative expert statements and clinical overviews for regulatory and Ethical Committee dossiers.
- Document Review: Medical and clinical validation of Core Company Data Sheets (CCDS), SmPCs, and product labelling