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Development and structuring of quality manuals, policies, procedures, and records aligned with GMP, WHO, EU GMP, US FDA, and ISO requirements.
Preparation and implementation of clear, compliant Standard Operating Procedures (SOPs) that support consistent operations and regulatory expectations.
Comprehensive support for internal audits, supplier audits, and regulatory inspections including planning, execution, response preparation and follow-up.
Guidance to meet evolving regulatory requirements including inspection readiness, remediation support and regulatory submissions assistance.
Implementation of systems promoting process optimization, performance monitoring and continual improvement aligned with quality risk management.
We conduct detailed and systematic gap analyses to identify compliance gaps, weaknesses, and improvement opportunities within pharmaceutical and regulated facilities. Our gap analysis compares current practices against applicable GMP, regulatory, and quality standards, providing a clear roadmap toward compliance.
Evaluate preparedness for inspections and audits, identifying critical and major compliance gaps.
Assess alignment with applicable GMP requirements including documentation, facilities, processes and quality systems.
Identify high-risk areas impacting product quality, patient safety or compliance and define mitigation strategies.
Develop practical and prioritized Corrective and Preventive Action (CAPA) plans with clear responsibilities and timelines.