Regulatory Safety and Health Authority Support
We have extensive experience supporting responses to safety-related questions from regulatory authorities worldwide across clinical development, post-marketing pharmacovigilance and major regulatory submissions. Our experience includes senior medical safety input into major regulatory submission programmes across oncology, diabetes, and infectious diseases.
Services include:
- Preparation and medical review of responses to health authority questions
- Development of scientifically robust and medically consistent company positions
- Preparation and review of safety sections within regulatory submission dossiers
- Medical input into integrated safety analyses and submission strategy
- Support for emerging or ad hoc safety issues
- Alignment of regulatory responses with risk-management documentation, prescribing information and the evolving product safety profile
- Safety support for regulatory meetings and inspections
Our experience includes providing medical and pharmacovigilance support to EU and International QPPVs, with oversight of product portfolios spanning multiple therapeutic areas.
QPPV Office support includes:
- Medical oversight of emerging and established product safety issues
- Support for Direct Healthcare Professional Communications and product-labelling updates
- Support for local affiliates implementing global and local pharmacovigilance requirements
- Participation in QPPV Office and affiliate-facing governance meetings
- Review and maintenance of the Pharmacovigilance System Master File
- Review of pharmacovigilance key performance indicators
- Assessment of new and evolving regulatory requirements
- Support for inspection readiness and oversight of pharmacovigilance system performance