REGULATORY COMPLIANCE SUPPORT:

1. ADVISORY SERVICES

• CGMP (Current Good Manufacturing Practice) Compliance

• Advisory services to queries pertaining to Pharma GMP, GLP, QA and

Regulatory Affairs

• Compliance audits as per current and updated statutory pharma regulations

• Gap Analysis

• Technical Due diligence for Mergers & Acquisitions

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2. TECHNICAL ASSISTANCE

• Site Master file as per PIC/s & Local FDA requirement

• Quantitative Risk and Assessment (QRA)

• Environment Impact Assessment (EIA)

• Safety Audits

• Energy Audits

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