GXP Consulting Services for Pharma Industry
GxP is a collection of quality guidelines and regulations created to ensure that pharmaceutical, biotech and medical device products are safe, meet their intended use, and adhere to quality processes during drug development lifecycle from IND to NDA/BLA to post marketing surveillance.
Pharmatek team consists of highly qualified and trained subject matter experts, we offer GxP consulting services in GCP, GLP, GVP, cGMP and CSV from product development through commercialization and beyond.
Our GXP consultants are acquaint with the latest regulatory requirements and equipped with contemporary tools and methods to assess the current status and provides quality solution to align with organization’s strategic and tactical goals. Our scientific and technical team assists with all types of projects from facility commissioning, monitoring, process improvement, QMS management, CSV qualification. .
For each assessment, we work with our clients to discuss their specific needs, review the company requirements, organizational structure, legal requirements etc., and determine the capabilities to be assessed and regulatory standards to be applied. All projects are reviewed and defined with clear scope and milestones with clients to ensure successful outcome and satisfaction.
Our teams of experts have successfully assisted international regulatory inspections for various global companies. They have hands-on experience of managing, helping for various international regulatory inspections including USFDA, MHRA UK, MCC South Africa, WHO Geneva, BfArM Germany, China NMPA, Korean MFDS, Taiwan TFDA, Swiss Medic, Health Canada and TGA Australia.
Pharmatek provides a wide range of consultancy services to clients as per their specific needs.
Range of services
- 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 support
- Process validation support
- Training support
- Inspection readiness support
- Environment and Utility monitoring support
- Information Security assessments