Independent GxP Audits · Regulatory, Quality & Compliance Consulting
Quality · Compliance · Integrity · Excellence
From independent GxP audits to regulatory affairs, engineering, pharmacovigilance and digitalization — one knowledge-based partner across the pharmaceutical lifecycle.
Genuine conflict-free independence, a global auditor pool and a verifiable audit-report database — the edge behind every engagement.
Every GxP, regulatory, quality, engineering and safety need under a single, coordinated partner.
A worldwide pool of qualified, independent auditors across India, Europe, the Americas, the Middle East and Asia.
Our own work runs on an ISO 9001:2015 certified quality management system.
Specialists behind 1000+ GxP projects and 1300+ audits for clients worldwide.
Competitive, transparent pricing — including shared audits — without compromising rigor.
Engagements scaled to your timeline, with reports delivered when you need them.
We anticipate risk and regulatory change so you act early, not reactively.
Modern, risk-based methods — including AI-assisted approaches — applied pragmatically.
Access verified GMP audit reports across 232+ manufacturing sites worldwide. Reduce cost and audit fatigue with shared, independent audits — and qualify suppliers faster with reports you can trust.
232 sites on record
From API and biopharma to medical devices, laboratories and distribution — regulatory depth tailored to your sector.
Every engagement follows a disciplined life-cycle, so you always know what happens next.
We define the engagement, applicable regulations, agenda and logistics — and agree confidentiality and access.
We review your documents and history so on-site or remote time targets the areas of real risk.
Qualified specialists deliver the audit or project with daily debriefs and full transparency.
You receive a clear, risk-ranked report — and we follow CAPAs through to verified closure.
“PharmExpert's auditors brought genuine independence and depth. Their GMP audit gave us a clear, risk-ranked view of our supplier and the confidence to make a sourcing decision quickly.”
Practical guidance from our specialists on the issues shaping pharmaceutical quality and regulatory affairs.
Audit milestones, event appearances and regulatory commentary from our team — straight from our company page.
PharmExpert
Jul 28, 2026
World Hepatitis Day — awareness is the first step toward prevention. Advancing healthcare knowledge and compliance across the pharmaceutical sector.
PharmExpert
Jul 28, 2026
On Guru Purnima we thank the mentors and industry experts who shaped our practice. Knowledge is the foundation of quality, compliance and continuous improvement.
PharmExpert
Jul 28, 2026
Meet us at IPHEX 2026, 7–9 September, New Delhi — Booth 3G-08. Talk to our team about EU GMP certification, facility design, MA acquisition, supplier audits and regulatory affairs.
PharmExpert
Jul 23, 2026
Welcoming Gaurav Bhargava as Associate Director — 22+ years across pharma and biotech, with deep expertise in GMP compliance, quality assurance, aseptic processing and validation.
PharmExpert
Jul 22, 2026
Independent GMP/GxP audits for vendor qualification — completed across APIs, finished dosage forms, medical devices and testing laboratories worldwide.
Talk to an independent PharmExpert specialist about your GxP, regulatory or quality challenge. We respond within one business day.
