GMP Consultancy

Ensure compliance. Enhance quality. Expand globally.

At IVITAA CONSULTANCY, our GMP consultancy services are designed to empower your pharmaceutical operations with end-to-end regulatory alignment and quality system implementation. We act as an extension of your internal team, combining deep domain expertise with real-world execution.

Our Core GMP Services Include:

Project Oversight & Compliance Monitoring:
Continuous tracking of GMP-critical activities to keep your operations audit-ready.

Regulatory Document Development:
Drafting and reviewing SOPs, validation protocols, quality manuals, and other key compliance documents tailored to regulatory expectations.

Quality Management System (QMS) Setup & Enhancement:
Structuring or refining your QMS for seamless alignment with FDA, EMA, WHO, and PIC/S standards.

Liaison with Regulatory Authorities:
Direct communication and coordination with national and international health authorities on your behalf.

Manufacturing Authorization Support:
Expert assistance in preparing and submitting documentation for GMP manufacturing licenses.

Market Authorization Advisory (CEP/DMF):
Strategic consulting for marketing authorization of pharmaceutical products and APIs, including dossier review and submission guidance.

We don't just advise. We implement. With IVITAA, your GMP journey is compliant, confident, and future-ready.