Regulatory Compliance
Mercodia is a GLP-approved laboratory, ensuring that your preclinical testing meets regulatory requirements set by various health authorities, such as the U.S. FDA and the European Medicines Agency (EMA). As a GCP-compliant laboratory, we ensure that the bioanalytical testing as a part of the clinical trials is conducted with the highest ethical standards, data integrity, and regulatory compliance. This not only safeguards patient safety but also enhances the credibility and success of your drug development endeavors.
Certifications
- GLP (OECD series on principles of good laboratory practice and compliance monitoring)
- ISO 13485:2016
- MDSAP (US and Canada)
Guidelines and compliance
- FDA Guideline for Bioanalytical Method Validation
- ICH M10 Guideline for Bioanalytical Method Validation
- EMA Guideline for Bioanalytical Method Validation
- ICH E6(R2) Guideline for Good Clinical Practice
- CLSI Standards
Guidelines for computerized systems and data integrity
- 21CFR Part 11 Electronic Records, Electronic Signatures
Certificates
Mercodia’s Quality Management System is certified to ISO 13485:2016 and MDSAP (US and Canada).
GLP Compliance
Mercodia operates in compliance with the principles of Good Laboratory Practice (GLP) as established by the OECD and the European Community at the time of the inspection.
If you have specific questions about our quality system, please email: quality-regulatory@mercodia.com
