MyAuditor specializes in ensuring regulatory compliance and quality assurance in pharmaceutical manufacturing worldwide. With a team of experienced professionals in Europe, India, and China, we provide comprehensive audits tailored to your needs, helping you meet global Good Manufacturing Practice (GMP) standards.
EXPLORE OUR OVERVIEW OF AUDIT REPORTS AVAILABLE TO PURCHASE.
Why choose MyAuditor?
Arranging an audit date, customer specific topics to be addressed, sharing agenda, conducting, issuing personalized reports and evaluating of CAPA plan, providing GMP declaration.
No commercial relationship between auditee and auditor (declaration can be provided upon request).
Our experts bring years of experience in GMP audits and pharmaceutical quality management and we support you in the communication with the authorities.
We understand the unique needs of each client and provide customized audits. Of course, all information is kept under confidential terms, including NDA/CDAs.
Stay ahead of industry regulations with our in-depth knowledge of pharmaceutical standards.
Services
Comprehensive EU regulatory compliance and GMP/GDP audits.
EU GMP/GDP compliant Audits
- Comprehensive assessments of manufacturing processes for regulatory compliance.
- Identification of areas for improvement and risk mitigation.
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).
- 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).
About us
Maurits Regouin
More than 25 years in the veterinary industry, managing various companies, having a worldwide network in API trade to product development and commercializing finished products.
info@myauditor.nl
+31 6 5050 7030
