GxP Quality & Regulatory Audit Services for Clinical Development and GMP Operations

In today’s stringent global regulatory environment, achieving and maintaining GxP compliance is critical for safeguarding product quality, patient safety, and market readiness. Techsol Life Sciences is a trusted partner for GxP Quality Management and Regulatory Audit Support, helping pharmaceutical, biotech, and medical device companies meet and exceed regulatory expectations across the clinical development and manufacturing value chain.

With over 15 years of global experience across U.S. FDA, EMA, MHRA, Health Canada, PMDA, and WHO regulatory frameworks, we provide end-to-end GxP audit services to ensure inspection readiness, risk mitigation, and lifecycle compliance.

Our Specialized GxP Audit Services

Techsol’s Specialized GxP Audit Services provide comprehensive compliance and quality oversight to ensure product quality, patient safety, and regulatory readiness. Our expertise includes Clinical Development Quality and GCP Compliance Audits, covering investigator sites, vendors, CROs, and trial processes to ensure GCP adherence and inspection readiness. We conduct GMP Compliance and Manufacturing Quality Audits to assess facilities, quality systems, and supply chain partners for global GMP alignment. In addition, our Integrated GxP Quality Management and Regulatory Audit Support includes cross-functional oversight, mock inspections, and end-to-end audit preparation to meet US FDA, EMA, MHRA, PMDA, and other international regulatory expectations.

Clinical Development Quality & GCP Compliance Audits

We help sponsors and CROs maintain ICH-GCP compliance and inspection readiness across all phases of clinical development:

Clinical Trial Site Audits (Investigator Sites, Hospitals, and Study Centers)
Sponsor/CRO System Audits & Vendor Qualification Audits
Pharmacovigilance System Audits (GVP Compliance)
Clinical Trial Master File (TMF) and Data Integrity Audits
Inspection Readiness Programs for USFDA, EMA, and MHRA

Key Outcome: Identify gaps, strengthen data integrity, and ensure regulatory compliance for clinical programs.

GMP Compliance & Manufacturing Quality Audits

Techsol provides comprehensive GMP audit services that align with 21 CFR Parts 210/211, EU GMP, WHO TRS, and ICH Q10 principles to maintain manufacturing and product release compliance:

API, Drug Product, and Biologics Manufacturing Facility Audits
Contract Manufacturing Organization (CMO) and Contract Testing Laboratory (CTL) Audits
Quality Management System (QMS) Gap Assessments
Data Integrity, Cleaning Validation, and Equipment Qualification Reviews
Pre-Approval Inspection (PAI) Readiness and CAPA Effectiveness Verification

Key Outcome: Ensure global supply chain reliability and regulatory approval readiness for commercial and clinical production.

Integrated GxP Quality Management & Regulatory Audit Support

We provide end-to-end audit lifecycle support, from planning and vendor qualification to regulatory inspection preparedness:

Development of Risk-Based Audit Programs (RBAP) aligned with ICH Q9 (R1) risk management principles
Mock Inspections & Gap Assessments to mitigate compliance risks proactively
CAPA Design and Effectiveness Verification for FDA, EMA, and MHRA audit findings
Digital Quality Metrics and KPIs for continuous improvement and regulatory intelligence monitoring
Training and Awareness Programs for internal and external stakeholders

Key Outcome: Achieve sustained inspection readiness, regulatory confidence, and faster time-to-market.

Value Proposition

Global Regulatory Expertise: Hands-on experience with multi-agency inspections and evolving regulatory expectations.
End-to-End Audit Solutions: Covering clinical development, manufacturing, pharmacovigilance, and supply chain operations.
Risk-Based & Digital-Driven Approach: Leverage industry 4.0 tools, data analytics, and quality metrics to reduce compliance risks.
Proven Track Record: Supported first-in-class therapies, biologics, and complex generics through successful FDA, EMA, and WHO inspections.