Quality audits

Quality audits

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We carry out supplier audits to verify compliance with the quality systems required by current regulations.

Our work includes:

  • Good Manufacturing and Distribution Practice (GMP/GDP) audits.
  • Assessment of suppliers and outsourced service providers.
  • Identification of deviations and preparation of corrective action plans.
  • Preparing your company for inspections by regulatory authorities.

Specific procedures

Disposición 3266/13

We help you comply with ANMAT Disposición 3266/13 (Good Manufacturing Practice for medical devices and in vitro diagnostic products). A disposición is a regulation issued by ANMAT, Argentina's national health regulator.

Disposición 6052/13

We help you comply with ANMAT Disposición 6052/13 (licensing for the interprovincial distribution of medical devices and in vitro diagnostic products).

Disposición 2069/2018

We help you comply with ANMAT Disposición 2069/2018 (Good Distribution Practice for medicines).

Need to audit your quality system?

Tell us about your situation and we'll arrange a tailored audit.

Contact us