GMP Approval & Compliance Services

We provide GMP readiness and audit preparation for EU-GMP, USFDA, WHO-GMP, PIC/S, TGA (Australia), Health Canada, ANVISA (Brazil), COFEPRIS (Mexico), and GCC nations.

Our vendor audits assess compliance with GMP standards in terms of documentation, infrastructure, process capability, quality systems, and regulatory history.

We assess the logical flow of materials and personnel, zoning, segregation, equipment placement, and overall facility design in line with GMP best practices.

CAPA and risk management are central to regulatory compliance. We help design proactive systems to detect, correct, and prevent non-conformities.

It’s a comparison of your facility’s practices and documentation against India's Schedule M guidelines. We identify gaps and recommend remediation.

Readiness depends on the initial gap and facility type, but our approach typically enables preparation within 4–12 weeks.

GMP compliance audits ensure that pharmaceutical manufacturing processes, facilities, and documentation meet global regulatory standards like EU-GMP, USFDA, and WHO-GMP, ensuring product quality and patient safety.

We provide on-site representation, mock inspections, audit response preparation, CAPA development, and follow-up support to address findings like FDA 483s or warning letters.

We prepare and review CTD/eCTD modules, NDA, ANDA, IND, IMPD, and DMF submissions, including CMC documentation and GMP sections, to ensure compliance and readiness for regulatory review.

The duration varies based on scope, but audits typically take 1–3 weeks, while facility qualifications (DQ/IQ/OQ/PQ) may take 2–8 weeks, depending on complexity.

Pharmaceutical manufacturers, biotech firms, API producers, and contract manufacturers benefit by achieving regulatory compliance, streamlining approvals, and ensuring quality systems.

Data integrity assessments verify that records and systems follow ALCOA+ principles, ensuring traceability and compliance with 21 CFR Part 11, which is critical for regulatory audits.