- Pharmaceutical Consultancy
- Medical Products
- Contract RP
Contract RP
Contract a Responsible Person (RP) registered with the Health Products Regulatory Authority (HPRA) to maintain a Wholesale Distribution Authorisation (WDA) to procure, hold, supply and export medicinal product.
FQS can provide contract responsible person’s (RPs) on a short-term basis e.g., to cover holidays, maternity / parental leaves i.e., Deputy responsible person or long-term contracts bringing experience and up-skilling staff in issue resolution.
The Responsible Person will implement and/or maintain your quality management system (QMS) and ensure regulatory compliance with Good Distribution Practice (GDP) guidelines and legislation, offering training services and all quality and regulatory support that your company needs. This will include the fronting of any HPRA inspections in accordance with the WDA.
Responsible Person (RP) Services
RP will compile, review, maintain and approve documentation and QMS to ensure compliance with Irish/EU/UK requirements.
- Implement and maintain Wholesale Distribution Authorisation and register with Health Products Regulatory Authority (HPRA) to store and distribute pharmaceutical product
- Experience with a vast range of regulatory authorities including HPRA, MHRA and FDA.
- Ensure compliance with Good Distribution Practice (GDP) Requirements, including, but not limited to documentation control and all stages of storage and distribution.
- Comply with EU GDP guidelines, HPRA/MHRA guidelines and EU/UK Legislation and ensure all the Principal Duties and Responsibilities of the Responsible Person (RP) are met.
- Competent authority inspection readiness and GDP auditing services
What we offer
FQS can provide contract responsible person on
Short-term basis
E.g. to cover holydays, maternity/parental leaves i.e. Deputy responsible person
Long-term contracts
Bringing experience and up-skilling staff in issue resolution.
