We offer GAP assessment GMP/GLP/GCP Audit, compliance solutions and providing documents and templates; sops; protocols and conducting Data integrity Training; GMP all the areas training; GLP and GCP training; QMS training at affordable cost. Founded by Mr. G Sundar ( https://www.linkedin.com/in/g-sundar-a3b39610/ ) with 25+ yrs of expertise in Good Manufacturing Practice (GMP) regulations, Quality System Regulation (QSR) and Part 11;EU GMP, the company offers vast variety of services in the field of compliance and regulations - 1. GMP Audits for API and Starting materials 2. Vendor Audits and Excipients Audits 3. Packaging Material Audits 4. Identification, execution of Third party manufacturing for site transfer and technological transfer of products.(API and Formulation) 5. Conduct of GMP Audit for third party manufacturers 6. Conducting trainings on behalf of MA holders and Qualified person (QP) 7. Complete GMP QMS documents implementation 8. Conducting onsite GMP trainings (USFDA/PIC(s)/WHO Geneva/Eu GMP/ANVISA 9. Function as delegated QP and to review compliance of batches exported to MA/ANDA holders. 10. SOP Services 11. GAP assessment audit services for intermediates; packaging and service vendors 12. Bioequivalence studies monitoring and CRO /study audits 13. Data Integrity compliance and Supporting Document s Auditing 14. Qualification and cleaning validation as per latest ADE/PPE concept. 15. Inspection Readiness / Pre-Approval GMP Inspection Audits 16. Serving for your External audit observations compliance and Monitor the CAPA 17. GMP Quality Systems improvement As per ICH Q8;Q9;Q10 (PQS)
