Global Regulatory Affairs

If your company envisions venturing into new market sectors and would, therefore, require a certification, then we can help you to become “audit-ready" for the following certifications:

GMP/ cGMP Pre Audits

If you are looking to enter a new market and require GMP / cGMP Certification, we can help by managing a pre audit and gap analysis report for you to get you ready in order to get the certification.

GDP Pre Audit

We can help you ensure that you are prepared fo the required GDP certification through a separate pre audit and gap analysis report.

GLP Pre Audit

The studies undertaken to demonstrate the health or environmental safety of new chemical or biological substances should be conducted in compliance with the principles of GLP.
We can help you to be ready for a GLP audit to ensure that are compliant with this regulatory requirement in the EU and other parts of the world.

We offer quality audits for various processes, including:

  • active substance manufacturers
  • medicinal product manufacturers
  • clinical trial activities.

Countries where we have already been active

Austria, Belgium, Brazil, Bulgaria, Canada, China, Finland, France, Germany, Holland, Hungry, India, Ireland, Israel, Italy, Korea, Lithuania, Macao, Poland, Portugal, Romania, Russia, Spain, Sweden, Switzerland, Argentina, Mexico, Turkey, the UK and the USA.

What we can do for you

  • Audits conducted by professional auditors.
  • Use of checklists adapted to individual client requirements and those corresponding to international regulations depending on the country where the products are to be marketed, or to the jurisdiction governing the type of activity.
  • Our auditors are qualified to audit against appropriate international checklists.
  • Audits are conducted according to our schedule and according to the items listed in our Appendix 1 (active substance or medicinal product manufacturing) and Appendix 2 (clinical trials), both of which will be provided.a

There are no boundaries to where our auditors can operate. So far, we have helped companies in Asia, the Middle East, Latin America and India.

Business Cases

Contact Us

If you are interested in our service please contact us for more information.

Telephone+353 125 44033

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