GLOBAL PHARMA CONNECTION-INDIA

RFQ Description

Dear Sir, We provide the following services to Pharma Companies . 1. Development of new facility, Quality Control and Quality Assurance Systems. 2. Assisting fillings of Drug Master Files in various countries. 3. Assisting registering products in various countries. 4. Supporting RA, for timely completion of DMF. 5. Assisting How to face Regulatory Audits. 6. Assisting to file Dosage forms in various countries. 7. Assisting Stock and Sale of API, Finished Dosage forms. 8. Assurance of all mfg Licenses, GMP, WHO-GMP, ISO-9001, ISO-14001 requirements.9. Assisting obtaining Indian Drug License, GMP, WHOGMP Certificates. 10. Assisting to get Halal Certificate from Muslim Food Board, Kosher Certificate, and AIB Certificate from American Institute of Bakeries. 11. Effective implementation of internal as well as external Audit system at regular interval with recommendations for a consistent improvement. 12. Organizing training programs for Production, QC, QA, and Warehouse. 13. Training of Quality Control, Quality Assurance and Regulatory Affairs personnel according to Indian Drug Control, USFDA, and ICH Guidelines. 14. Performing periodic Internal Audits to ensure that the current systems are in practice. 15. Performing Vendor Audits for Raw Materials as third party audit, evaluate and recommendation. 16. Assisting effective use of used solvents. 17. Assisting in preparation of Tech Packs for various customers. 18. Assisting in Preparation of Site Master files. 19. Preparation, periodic revision of SOP and Standard Testing Procedures for QC, QA Production, Maintenance, Warehouse HR departments. 20. Equipment Qualification and validation. 21. Process and cleaning validation. 22. Ensuring Plant, Personnel & Equipment Hygiene and Pest Control bulk drugs, bulk drug intermediates, api PHARMA