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MyAuditor.nl is a start-up consultancy specializing in Good Manufacturing Practice (GMP) audits for the pharmaceutical industry all over the world. With a team of experienced professionals located in Europe, India and China, we offer comprehensive services to ensure regulatory compliance and quality assurance in pharmaceutical manufacturing.

OUR EXPERTISE

Audits of Raw material (API/DS) manufacturers

Audits of Finished Dosage Form (DP) manufacturers (including vaccines and biotech)

Audits of Packaging manufacturers (ISO15378)

Audits of Warehouses and Distribution Centres (GDP)

Explore our Overview of audit reports available to purchase

Audit reports

Why Choose MyAuditor.nl?

Turnkey

Arranging an audit date, customer specific topics to be addressed, sharing agenda, conducting, issuing personalized reports and evaluating of CAPA plan, providing GMP declaration

Conflict of Interest

No commercial relationship between auditee and auditor (declaration can be provided upon request)

Experienced Team

Our experts bring years of experience in GMP audits and pharmaceutical quality management and we support you in the communication with the authorities

Tailored Solutions

We understand the unique needs of each client and provide customized audits. Of course, all information is kept under confidential terms, including NDA/CDAs

Regulatory Compliance

Stay ahead of industry regulations with our in-depth knowledge of pharmaceutical standards

Services

EU GMP/GDP compliant Audits

  • Comprehensive assessments of manufacturing processes for regulatory compliance.
  • Identification of areas for improvement and risk mitigation.

General compliance to EU regulations

  • Design and implementation of robust quality management systems.
  • Continuous improvement strategies to enhance overall quality.
  • Stay up to date with changing regulations and ensure compliance with global standards.
  • Assistance in preparing for regulatory inspections (mock inspection).
  • Assistance in preparing for regulatory inspections (mock inspection).
  • Full support with your QA GMP due diligence responsibilities covering China/Taiwan/India for supply to Europe.
  • Documentation and reporting for regulatory submission.
  • General communication and a better understanding with competent authorities
  • Importation and QP certification.
  • Batch testing (TOI).

Contact us

Maurits Regouin

info@myauditor.nl 

+31 6 5050 7030

More than 25 years in the veterinary industry, managing various companies and having a worldwide network in API trade to product development and commercialising finished products.

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Jurgen van Turnhout

info@myauditor.nl

+31 6 8205 2752

Auditor since 2000, worldwide auditing in over 300 companies from GDP to API GMP to FDF GMP. For biotech, vaccines as for pharmaceuticals.

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We use local auditors/partners as much as possible

Audit reports

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