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.
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Audit of service providers (e.g. laboratories, storage sites, manufacturing sites)
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Audit of active substance, excipients and packaging manufacturers
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GxP Training/Courses on specific topics, including regulatory/guideline changes, etc.
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Consultancy for creating/improving the quality management system preparation
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Audit for the evaluation of the degree of conformity before the NAMMD inspection and consulting for inspection
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Guidance on understanding the deficiencies received during the inspection and drafting the action plan
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Consultancy for various aspects of regulatory interpretation in the two areas (GMP/GDP)
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Ensuring Qualified person services