Pharma Quality First LLP

Pharma Quality First LLP is the GMP Consulting and Auditing firm owned by Ravi Chinchalkar. The firm is extensively engaged in conducting GMP Audits and Consulting services for various global customers. Following services are rendered by Pharma Quality First LLP - Conducting GMP audits of various API and intermediate suppliers - Support for the Clinical Trials API supply from R and D scale - Support in establishing and maintaining the quality compliance of the API facility - Non-compliance gap assessment and remediation support. - Batch release support with complete due diligence - Guidance for drafting SOPs and other important QMS documents - Support for conducting a mock audit, audit readiness, and CMO qualification - Due diligence and gap analysis for mergers and acquisitions. - Set-up of Computer Systems and ITQA compliance - Training on key topics of the Pharmaceutical industry - Support for various types of regulatory filings - Support for Primary Packaging materials audits - Support for Clinical Trials Ravi Chinchalkar holds a Master's degree in Organic Chemistry from Nagpur University with project management and CSV certificates, having rich experience of two decades in diversified sections of the API industries. Ravi did job with with various topmost and global companies in India, i.e. Lupin, Orchid, Dr Reddy’s Lab (DRL). His extensive experience covers API-process validation, cleaning validation, deviation investigation and CAPA, computer system validation, auditing API manufacturing, and testing facilities, hosting customer audits, oversight of CMOs activities, Quality risk management (QRM), employee training program, handling of complex investigations, remediation and compliance activities, establishing process validation strategies, and implementing of QMS systems in new facilities.