Equipment Qualification
Facility Qualification
HVAC/AHU System Qualification
Dr.Rajendra Chavda is Director in APC pharma group
he has vast experience of more than 25 years in the Pharmaceutical Industry including Sun Pharmaceutical Industries Ltd., Lupin Ltd., Torrent Pharmaceutical industries ltd, Zydus Cadila Healthcare, Macleods Pharmaceutical Ltd. and BDR Life Sciences Pvt Ltd. In his current role he leads a team of experienced individuals overseeing Research & Development, Quality Control,
Mr Patel delivers the strategic guidance and direction toward implementation of effective solutions for client needs. As an expert in compliance enhancement, he develops program solutions to meet GxP compliance requirements and works with industry senior management to restore healthy company relationships with regulatory authorities.
Mr Patel has extensive experience covering the gamut of R&D through post-marketing surveillance. He assists and counsels senior-level management in areas of Corporate Governance, Corporate Integrity Agreement Compliance, Consent Decree Negotiations and Resolutions, Application Integrity Policy resolution, Due Diligence evaluations (facilities; products; technologies), and provides leadership, direction and management of the APC Pharma groups operations as well as Corporate services including Legal and Financial services and administration.
He is an expert in Regulatory Submission and Vendor Audit. Mr. Bhavesh Dhrangdhria Certification Regulatory Affiars. He has wide experience face regulatory audit as per certification USFDA,EDQM,PMDA,KFDA,TGA,EDQM-COS,WHO-GMP,WC,FSSC,Fssai,FAMI QS,ISO ,GMP,GLP etcand DMF/eCTD filed more than EU & USDMFs and many products in CDSCO.
He is expert in DMF/Dossier/eCTD filling in all regulatory body and maintain product life cycle. He is an expert in developing QMS system. He is passionate about educating and training as per new guidelines fellow employees in getting a deep understanding of their respective areas of operations.
Quality Assurance, Regulatory Affairs and Production.He is an expert in development of API,Process Scale-Up, Technology Transfer and Regulatory Affairs. Dr. Rajendra has 31 national & international patents and 5 international publications. He has developed and scaled up over 100 products and filed more than 25 EU & USDMFs and many products in CDSCO. He is expert in DMF filling in all regulatory body and maintain product life cycle.
He is an expert in developing cost saving techniques to achieve optimal yield while saving resources. He has a proven track record in Synthetic Organic Chemistry Research for Bulk Drug APIs for Regulatory as well as domestic market. He is passionate about educating and training fellow employees in getting a deep understanding of their respective areas of operations.
