Your Partner for Global Regulatory, GMP Services & Third-Party Audits.
Your Partner for Global Regulatory, GMP Services & Third-party audits.
Third Party Vendor Audits, EU QP Audits
& Technical Due-Diligence

Third Party Vendor Audits, EU QP Audits & Technical Due-Diligence

Leveraging expertise to drive quality compliance across the supply chain through three core service offerings:

Third-Party Audits

  • Conduct independent GMP compliance audits led by ISO-trained Lead Auditors, including audits on behalf of EU QPs to assess API, excipient, intermediate, bulk product, and formulation sites prior to regulatory submission or commercial launch
  • Leverage our India-based presence to offer cost-effective audit services, helping European companies reduce operational costs while maintaining high-quality standards
  • Identify inefficiencies, risks, and compliance gaps within supplier networks, enabling improved transparency and stronger supply chain control
  • Provide complete audit deliverables, including a detailed audit report, CAPA preparation, and submission—valid for up to three years
  • Ensure suppliers meet stringent pharmaceutical quality requirements, supporting product safety, efficacy, and regulatory readiness
  • Reduce the likelihood of major observations during regulatory renewal inspections through the authority-level expertise of our audit team
  • Deliver actionable, timely insights that support data-driven decision-making and supplier qualification strategies

Vendor Qualification & Supplier Verification

  • Comprehensive supplier assessments for pharmaceutical and medical device manufacturers focusing on GMP and ISO standards
  • Key evaluation areas include:

Quality Management Systems (QMS)—ensuring processes are controlled, documented, and compliance-focused

Documentation & record-keeping—verifying traceability and data accuracy

Personnel training & qualification—confirming staff competency for critical tasks

Product quality control—ensuring products meet specifications and are manufactured under proper controls

Process validation—verifying consistent outcomes and reliability

Risk management—ensuring proactive identification and mitigation of product and process risks

  • Our structured approach ensures suppliers are compliant, traceable, and aligned with regulatory expectations

Technical Due-Diligence for Mergers & Acquisitions

  • Independent, unbiased consulting for investment decisions, divestments, or site acquisitions
  • Services include:

Site/company evaluation and capability ranking

Technical opinions in insolvency cases

Risk mitigation planning for US/EU GMP gaps, warning letters, import alerts, and non-conformances

Assessment of product pipeline robustness—including ANDA, MAA, CEP, DMF statuses

Commercial portfolio viability analysis

  • Our domain experts offer clarity and confidence to both financial and pharmaceutical stakeholders