GMP Auditing
Documentation reviews, GMP inspections support, liaison with authorities, and product-specific compliance checks (e.g., shared facilities).
Medwisdom LifeScience is regularly engaged in GxP audits and related services. We conduct GLP inspections, GMP technical and documentation reviews, and support due diligence for third-party contractor selection or strategic reviews.
Our independent, expert-led audits help identify compliance gaps, ensure readiness for regulatory inspections, and strengthen quality systems — giving you confidence in your operations and partners.
Contact Us
Thorough audits protect your quality systems, reduce regulatory risk, and ensure readiness for inspections — helping you maintain compliance and protect your business reputation.
Early detection of compliance gaps before they become regulatory issues.
Prepare confidently for regulatory inspections and third-party audits.
Minimize potential non-compliance findings and costly delays.
Verify third-party contractors and suppliers meet GxP standards.
We deliver independent, expert GxP auditing and inspection support tailored to your needs:
Documentation reviews, GMP inspections support, liaison with authorities, and product-specific compliance checks (e.g., shared facilities).
Independent GLP audits, pre-inspection readiness assessments, and technical/documentation reviews for non-clinical studies.
Pre-audit assessments for ISO 9001 and ISO 13485 Quality Management Systems, gap analysis, and remediation planning.
Regulatory and GxP due diligence for third-party contractors, acquisitions, partnerships, or licensing evaluations.
On-site support during regulatory inspections, authority liaison, and post-inspection response preparation.
Detailed gap assessments across GMP, GLP, QMS, and regulatory requirements with actionable remediation plans.
We bring independent expertise, deep GxP knowledge, and practical solutions to strengthen your compliance posture:
Unbiased audits with complete confidentiality — no conflicts of interest.
Deep experience across GMP, GLP, GDP, ISO 9001/13485, and major regulatory frameworks (FDA, EMA, CDSCO, etc.).
Timely audits with clear findings, prioritized recommendations, and remediation support.