Regulatory and Third party Audits

We have a multidisciplinary team of industry, regulatory, and scientific specialists who helps organizations to prevent and resolve compliance problems and to develop efficient and effective strategies for the submission and approval of drugs, biologics, and devices. The company deploys only highly experienced consultants who consistently deliver top-quality results for a diverse base of global clients—including pharmaceutical biologic, biotechnology, medical device, and dietary supplement companies and the law firms that serve them.

We work with you to conduct a GXP Audit of your facilities, systems or procedures to support your programme for achieving and maintaining Permanent Inspection Readiness at your site. We can also advise you on preparing for an upcoming inspection by a regulatory agency.

Prior to audit, our consultants will agree with you on the appropriate form for the post-audit report. This can range from a tabulation of findings to an in-depth analysis of gaps and development of a risk-based programme of remediation activities.

Attaining a sustainable state of Permanent Inspection Readiness is the primary objective. To achieve this, it is necessary to ensure that a robust and effective Pharmaceutical Quality System is in place, and to monitor its ongoing effectiveness and suitability through periodic GXP Audit and quality management review

Our consultant will provide GXP audit services for

  • GMP (good manufacturing practice) for intermediates, active pharmaceutical ingredients (APIs), and finished drug products
  • Q SR (medical device “GMP”)
  • GCP (good clinical practice)
  • GLP (good laboratory practice)
  • DEA (Drug Enforcement Agency).

Consultant have high end expertise in :

  • Perform “mock”FDA pre-approval inspections-helping to ensure that problem areas are identified and addressed before the organization face real inspection.
  • Verify activities of the regulatory committee.
  • Develop drug diversion prevention and counterfeit investigation programs.
  • Develop and Qualifying vendors.
  • Perform due diligence.
  • Conducting regulatory audits.
  • Auditing documentation, including application integrity audits.