🌍 Comprehensive Pharma Quality Audits, Contract & Compliance Services

We provide end-to-end Quality, Compliance, and Regulatory support to help global pharmaceutical, healthcare and life-science companies achieve GxP excellence, audit readiness, and operational efficiency.

✅ Quality Audits & Compliance

Conducting third-party GxP audits, vendor/supplier audits, and external audits aligned with international regulatory standards.

Ensuring any-time readiness for regulatory inspections and customer audits.

✅ Investigations & CAPA

Investigation of OOS, OOT, OOE, OOC, deviations, market complaints, lab incidents, returns, and data integrity issues.

Identifying true root cause and implementing effective, sustainable CAPA.

✅ Regulatory Documentation & Filings

Compilation and submission of regulatory filings as per global requirements.

Preparation and review of SMF, VMP, SOPs, protocols, and Quality Plans.

Responsible for preparation of all GxP documents.

✅ QMS Implementation & Continuous Improvement

Implementation of QMS, cGMP systems at both site and corporate levels.

Effective implementation of Change Control, QbD, 5S, Kaizen, Cpk, Six Sigma, PLM, FMEA, FMECA, and risk-management systems.

✅ Validation & Qualification Services

Conducting process, cleaning, transport, and equipment validations.

Preparation and review of URS, DS, DQ, FS, RA, IQ, OQ, PQ.

Supporting route scouting and new product launches with R&D/ARD teams.

✅ Quality & Technical Documentation

Preparation and review of Quality Risk Assessments, Impact Assessments, and Quality Metrics.

Review of QC/Micro data, SOPs, STPs, BCRs, BPCRs.

✅ Training & Capability Building

Conducting internal and external trainings using effective learning methodologies for all pharma functions.

✅ Cost Optimization & Process Improvement

Implementation of cost-saving and cost-reduction initiatives, improving process efficiency and reducing operational burden.

🌐 Elevate your GMP with expert Supplier audits

vGMPsolv💊💊💊

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