Credent team has a wide range of expertise in the area of GMP compliance support and can help the clients in following ways:

• Due Diligence Audits, cGMP compliance audits, Risk Based audits, and Mock Preparatory audits of manufacturing facilities, quality control laboratory, and Utilities as per cGMP requirements of FDA, MHRA and other agencies of the world.
• GMP training support as per requirements of major health agencies like USFDA, MHRA, ANVISA Brazil and other agencies.
• Document review support including raw data review as applicable for areas like Deviations, OOS, Change Controls, Market Complaints, BMRs, Validation reports, Stability Data, QC instrumental data, and Microbiology data.
• Support in drafting adequate response to FDA 483 observations and FDA Warning Letters.
• Third party review of Data Integrity issues and making reports for submission to FDA and other agencies.
• Supporting in Root Cause Investigations and CAPA strategies.
• Assistance in SOP preparation, Protocol Preparation and other GMP documentation.
• Part 11 Compliance support and training for QC laboratories.
• Expert review and advice on facility design, qualification and new project commissioning.