We cater for all your Regulatory and Quality support needs.
Our Regulatory and Quality services team consists of professional and experienced Regulatory and Quality executives, who have wide experience and expertise within the Life Sciences industry, especially within Medical Devices, Pharmaceuticals, Biologicals and Diagnostics. We have worked around the world, but have greatest experience in Europe, the USA and in the Far East. We are experts at interfacing with manufacturers, customers and regulatory agencies across the world.
We can help you with:
- Product CE Marking and Registration
- Mock FDA inspection
- Process and Equipment Validation
- New Product Design Histroy Files
- Annual Product Review
- Periodic Document Review
- Change Management
- Sterilisation Services - Control and Validation
- Inspection Preparation
- Support in the Resolution of Audit Findings
- Product Claims and Product Stability Support
- Recall Support
- Translation services
- Vendor and Internal Auditing
- Quality Systems Support
- Other services at your request
All of our client work is carried out with the highest degree of professionalism and confidentiality, and we are used to meeting both European and FDA requirements.
You Ask .... We Provide
Call us for a confidential discussion on your individual needs. Phone us on +44 (0) 7523876854 or email us at firstname.lastname@example.org