Question 1

What does OECD GLP compliance mean?

Accepted Answer

OECD GLP compliance means that the planning, conduct, monitoring, reporting, and archiving of non-clinical studies are carried out in accordance with internationally accepted quality standards.

Question 2

Do you operate in accordance with OECD GLP principles?

Accepted Answer

Yes. Our laboratory operates in full compliance with the OECD Good Laboratory Practice (GLP) principles, ensuring that all non-clinical studies are conducted in accordance with strict standards for quality, documentation, and data integrity. Our GLP-compliant system is supported by a robust Quality Assurance framework and regular inspections by regulatory authorities, ensuring that all data generated is reliable, traceable, and suitable for submission to international regulatory bodies.

Question 3

Is your laboratory inspected by regulatory authorities?

Accepted Answer

Yes. Our laboratory is regularly inspected by the relevant regulatory authorities to ensure ongoing compliance with Good Laboratory Practice (GLP) standards and applicable international guidelines. These inspections verify the integrity of our quality systems, study conduct, documentation practices, and data management processes, ensuring that all results meet the expectations of global regulatory agencies.

Question 4

Are your studies internationally recognized?

Accepted Answer

Yes. Our studies are internationally recognized when conducted in accordance with OECD Good Laboratory Practice (GLP) principles under the OECD Mutual Acceptance of Data (MAD) system. This ensures that our study reports and the data obtained are recognized by regulatory authorities in OECD member countries, supporting global product registrations and regulatory submissions without the need for retesting in different regions. Additionally, reports issued by our laboratories accredited to the ISO/IEC 17025 standard may be recognized internationally if the accreditation body is a signatory to the ILAC MRA (International Laboratory Accreditation Cooperation - Mutual Recognition Arrangement).

Question 5

What is the OECD Mutual Acceptance of Data (MAD) system?

Accepted Answer

The OECD Mutual Acceptance of Data (MAD) system is an international agreement that enables regulatory authorities in participating countries to accept non-clinical study data generated in accordance with the OECD Good Laboratory Practice (GLP) principles. This system helps streamline regulatory submissions, reduce costs, and support access to the global market by eliminating the need to repeat tests in different regions, while maintaining high standards for data quality and reliability.

Question 6

What does the ILAC MRA agreement mean?

Accepted Answer

The ILAC MRA is an international agreement aimed at ensuring the mutual recognition of test and calibration results issued by accredited laboratories across different countries. This system helps reduce the need for retesting while enhancing technical reliability.

Question 7

In which areas do you offer preclinical studies?

Accepted Answer

We offer a wide range of preclinical research capabilities to support early-stage development and regulatory safety assessments. These include in vitro toxicology studies, biocompatibility testing, microbiological and efficacy assessments, as well as other preclinical safety evaluations conducted in accordance with OECD GLP principles when required. Our services are designed to generate reliable scientific data that supports regulatory submissions and guides clinical development pathways.

Question 8

Can studies compliant with OECD GLP be used in FDA submissions?

Accepted Answer

Yes. Studies conducted in accordance with OECD GLP (Good Laboratory Practice) principles may be evaluated by international regulatory authorities, including the FDA, under the OECD Mutual Acceptance of Data (MAD) system. Final acceptance depends on the scope of the study, data integrity, and compliance with relevant regulatory requirements.

Question 9

Do you operate in accordance with the ISO/IEC 17025 standard?

Accepted Answer

Yes. We provide services through our group of laboratories, which hold comprehensive ISO/IEC 17025 accreditation.

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