- Pharmaceutical Consultancy
- Medical Products
- Quality and Regulatory
Quality and Regulatory
FQS deals with a vast range of regulatory bodies nationally and internationally (e.g. HPRA, FDA, MHRA, NB), ensuring compliance with customer and regulatory requirements. Our company have the global knowledge and expertise and have built up a strong global client base over the last number of years.
We have a wide range of experience of many of the typical issues and problems facing companies globally and we can help you to resolve these issues.
FQS offers expert consultancy services in the medicinal quality and regulatory fields, tailored to the clients needs.
SECTOR COMPLIANCE CONSULTANCY SERVICE & PROJECT WORK WHICH INCLUDES:
- Regulatory readiness and submissions
- Regulatory and GxP assessment and support
- Quality Management System Implementation (for new systems)
- Inspection readiness programs
- GDP Passport
- Quality and Regulatory compliance assessment and Reviews (for existing systems)
QMS Activities Support:
- Auditing (cGMP/cGDP/cGLP)
- Service providers approval
- Risk assessments
- Improvement projects and investigational work.
- Investigations, Closure of CAPAs and non-conformances
- Consultancy Work
- Training
Validation Activities:
- Process Validation
- Temperature Mapping
- Route qualification & Transport Validation
- Importation and batch certification
What we offer
Project assignment
Our experienced team will be supporting your projects tailored to individual needs.
Pre-purchased consultancy hours
A minimum of 10 hours are pre-purchased, and these may be used to discuss various items, on a remote consultancy/telephone support basis. FQS offer a complete private and confidential telephone support service to our clients, where we provide unlimited on – going advice and guidance on key aspects of Pharmaceutical manufacturing and distribution.
Long term contracts
Tailored to clients' needs.
