Qualified Person, Regulatory and Quality Assurance Services

Farmalyse offers qualified person (QP) and regulatory services from a pool of two in-house QPs and two external QPs based on the requirements and specifications of our sponsor.

Quality assurance (QA) services include:

• Liaising with relevant EU authorities for submissions and evaluations
• Preparation of CTD
• Registrations of dossiers
• CoS
• Independent site-audits
• DMF and document writing
• Protocol preparation
• Consultancy and related services

Please contact us for a full list of our QA and consultancy services.