GxP Consulting Services

GXP Consulting Services

Traceability and Accountability

Pharmatek Solutions offers comprehensive GxP consulting services, tailored to meet your specific needs throughout your product lifecycle. Our team of highly qualified experts has extensive experience in GCP, GLP, GVP, cGMP, and CSV, ensuring compliance with international regulations.

With extensive experience working with global regulatory agencies, including the USFDA, MHRA UK, MCC South Africa, WHO Geneva, BfArM Germany, China NMPA, Korean MFDS, Taiwan TFDA, Swiss Medic, Health Canada, and TGA Australia, we understand the unique requirements of different markets.

Whether you need a comprehensive gap assessment or targeted support for specific requirements, Pharmatek Solutions is your trusted partner. Our experts can help you identify areas for improvement, develop effective strategies, and achieve regulatory compliance.

GxP Consulting services include:

GAP Assessment of GLP, GCP, cGMP, GVP

Strategy Consultancy for Compliance

Addressing Quality Events, Deviations, Incidents, Investigations, and Reports
Preparation and Implementation of Validation Protocols
Review of Master/Executed Batch Records, Specifications, Test Methods, Validation and Stability, Protocols, and Reports
CAPA Program Management
Risk Management and Mitigation Plan

Equipment Qualification Support

Computer System Validation

Process Validation Support

Training Support

Inspection Readiness Support

Environment and Utility Monitoring Support

Information Security Assessments

Other Quality Services

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Pharmatek Solutions Inc. is an integrated Validations, Clinical, and Quality business solutions provider to global life sciences companies.