GXP Consulting Services - Traceability and Accountability
Our team consists of highly qualified and trained subject matter experts. We offer GxP consulting services in GCP, GLP, GVP, cGMP, and CSV from development through commercialization.
At Pharmatek Solutions, we have hands-on experience meeting the requirements of and managing communications with various international 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.
Whether you require a gap assessment to determine your weaknesses or have specific requirements that you need filled, Pharmatek Solutions has you covered.
Our range of 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
Inspection readiness support
Environment and utility monitoring support
Information security assessments