GxP Consultancy & Audits

With many years of practical experience within the industry as well as the national regulatory body, we can offer you a broad portfolio of services to support your organization in the maintenance, assessment and improvement of your GxP Quality Management System.

  • Audit of service providers (e.g. laboratories, storage sites, manufacturing sites)

  • Audit of active substance, excipients and packaging manufacturers

  • GxP Training/Courses on specific topics, including regulatory/guideline changes, etc.

  • Consultancy for creating/improving the quality management system preparation

  • Audit for the evaluation of the degree of conformity before the NAMMD inspection and consulting for inspection

  • Guidance on understanding the deficiencies received during the inspection and drafting the action plan

  • Consultancy for various aspects of regulatory interpretation in the two areas (GMP/GDP)

  • Ensuring Qualified person services