Services of a responsible person for a product
As an integral part of our comprehensive system of vigilance activities we are providing the services of a responsible person for your product in member states and/or in EU (e.g. EU Qualified Person for Pharmacovigilance, Responsible Person for Regulatory Compliance, etc.) and, thus, we take care of:
- setting a Responsible Person’s Office with necessary proof of contracts and company organigrams that assure meeting your legal obligations to competent authorities
- establishing validated and continuously maintained system of 24/7 availability of a responsible person and his/her deputy for competent authorities
- establishing network of responsible persons in member states linked to a responsible person on the EU level with necessary system of proof of qualifications, data exchange and information flow
- assuring necessary level of oversight of the vigilance system of your product by a responsible person
- assuring availability of a Responsible Person in case of an inspection.