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 Practise
- CLSI Standards
Guidelines and regulations for computerized systems and data integrity
- 21CFR Part 11 Electronic Records, Electronic Signatures
