Effective management of Regulatory Inspections is critical to their outcome and your success. If you are new to EU Regulatory inspections or if you would like to improve your ways or working we can assist.
What We Offer
We have extensive experience of Regulatory Inspection Management- both hosting and executing inspections. We can offer solutions and training to improve how you handle Regulatory Inspections and their complexities.
INSPECTION MANAGEMENT PROCESSES
We can provide advice on how to optimise your Inspection management processes and ways of working. We can offer on-site support to suit your needs.
- Inspection Management design & implementation
- Coaching & dry runs of topics
- Back-room operational support
We can help you to design robust, realistic and lean responses to regulatory inspection deficiencies
- Standard process for CAPA design
- Advice & guidance on commitments
RamsayPharma have extensive experience in supporting inspections by a range of regulatory authorities (US-FDA, EMA etc.). We can help you prepare, conduct and respond to inspections.
Coaching & Prep
RamsayPharma can assist you during your inspection. We offer coaching, support and back-room prep for SMEs, hosts and your team. Let us help you make the best impression.
RamsayPharma can assist you in preparing, structuring and optimizing your inspection responses. We can assist in interpreting deficiencies, designing good CAPA and drafting responses.