Risk management
Our Pharmacovigilance services includes a team of industry experts in the field of Risk Management planning and strategy, many with FDA and MHRA backgrounds.
WE CAN HELP YOUR ORGANIZATION WITH
- Data and dictionary management
- Pre-registration development
- Post-approval product safety studies
- GxP Compliance Strategies
- GxP audits
- Pre-approval inspection (PAI) readiness
- Operational readiness and sustainability programs (mentoring)
- Assistance during inspections/post-inspection correspondence and meetings
- Assistance to legal counsel in FDA enforcement matters
- Due diligence of product and facility acquisitions
- Training in GxP compliance and topical issues