GDP CONSULTANCY

Consultancy providing services for Medical Device and Pharmaceutical Industry. Providing Regulatory Affairs -Medical Devices, In Vitro Diagnostics Clinical Regulatory Affairs- Clinical Evaluation Reports, Performance Evaluation Reports, SSCP/SSP Post-Market Surveillance- Medical Devices, Post-Market Clinical Follow-up, PMCF Survey Development & Execution, Periodic Safety Update Reports, Quality System Integration, In Vitro Diagnostics, Post-Market Performance Follow-up Periodic Safety Update Reports, Quality System Integration Quality Management Systems- Audits and Inspections, Quality System Regulations, Acquisition Integration Consultancy on how to obtain and maintain a WDA, Experts in building and implementing Quality Systems ISO 13485, ISO 9001, ISO 14001 and GDP. Acting as RP on WDA licence. Acting as UKRP for Medical devices clients and help and build Technical Files for Class 1, Class 1s, Class IIa, Class IIb, Class III medical devices

• Employees 2