GXP Audits and Expertise
Estima has cut a niche in providing complete GxP consultancy services to pharmaceutical organizations.
- Our GxP team comprises consultants offering services in GxP consultancy. We have so far successfully cleared 30 International Regulatory Audits for various companies which include MHRA, USFDA, BSG Germany, TGA Australia, Korean FDA, HPFBI Canada, MCC South Africa and WHO Geneva.
- Service ranges from reviewing and upgrading the quality management systems to comprehensive oversight of vendors, systems, manpower and regulatory certification. The highly experienced teams of EPS offers fast, efficient and accurate consultancy, providing precise support to reach beyond industry standards.
- Significant experience in assisting pharmaceutical companies to achieve GMP-compliant quality management systems. Our quality assurance consultants help identify quality system requirements for full GMP compliance.
- We work with clients directly or indirectly as required to identify and develop a relevant quality management system, structure and appropriate documentation set.
- Perform QA and GMP compliance audits and advise clients on the best QMS for their needs.
- Carry out Greenfield projects from contractor selection process, routine contractor GMP reviews, and in-depth audits for specific projects, covering facilities, quality systems, manufacturing, packaging, analytical and engineering operations.
- Help companies obtain a successful conclusion to regulatory agency inspections through thorough preparation, ongoing consultancy and support to in-house experts, plus on-site support during the inspection itself.
- Using our own resources and those of our associates, we provide qualified auditing teams specifically tailored to requirement, and with the right blend of expertise and experience to deliver desired results.