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GMP AND GDP SERVICES
Pharmaceutical consultants
Qualified Person and Quality Expert Services
RP services
Pharmaceutical Quality System Services
Training Services
Strategic Planning for Expansion – New Markets
Regulatory Inspection Preparation
Post-Regulatory Inspection Support
Auditing Services
GAP Analysis and Risk Assessments
Testing Recall Process
Networking
supporting global quality in the
manufacture and distribution of medicine
GMP AND GDP SERVICES
Pharmaceutical consultants
Qualified Person and Quality Expert Services
RP services
Pharmaceutical Quality System Services
Training Services
Strategic Planning for Expansion – New Markets
Regulatory Inspection Preparation
Post-Regulatory Inspection Support
Auditing Services
GAP Analysis and Risk Assessments
Testing Recall Process
Networking
Regulatory Inspection Preparation
Covers GMP and GDP inspections
Support companies in obtaining EU GMP certification
Specialise in preparation for MHRA (Medicines and Health Regulatory Authority) inspections
We create and follow through checklists for inspection readiness
Provide general staff training on MHRA inspection requirements
Creating a list of stationery and electronic systems required for the inspection
Setting up electronic systems to support ’back room’ and ’front room’ communications
Conduct audit rehearsals – for lead and support functions
Conduct Pharmaceutical GMP and GDP Gap analysis audits
Conduct Risk assessments
Perform Quality Control checks on documents to be reviewed at the Regulatory Authority inspection
Prepare and review Standard Operating Procedures
Organisation of the ’back room’ for MHRA inspections – preparation for efficient retrieval of documents
Organisation of ‘front room’ Q&A sessions
Perform mock inspections
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