We evaluate your current manufacturing practices against applicable GMP regulations and identify gaps that need remediation.

From cleanroom layout to equipment qualification, we provide consultation to ensure your production environment meets GMP standards.

We help you create and organize standard operating procedures (SOPs), batch records, and quality manuals tailored to your product and region.

We design and implement robust QMS frameworks aligned with ISO 13485, ICH Q10, or WHO GMP.

Train your team with the latest GMP requirements and conduct mock audits to prepare for inspections with confidence.

We support pre- and post-audit activities including CAPA (Corrective and Preventive Action) planning, documentation response, and audit remediation.