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Regulatory Information and Accreditations
We are committed to ensuring safety and quality through compliance with global regulatory requirements
Precision has a core commitment to delivering quality by every measure. We work with regulatory authorities and accrediting organizations around the globe to ensure that our processes and protocols reflect the latest guidelines-and to give our customers the assurance that we consistently meet the highest standards. With quality built into our strategies and procedures, it’s a mindset that governs everything we do.
Precision's QMS, regulatory, and compliance standards
Recognized Quality Management Systems, Licenses, and Accreditations
- ISO 9001 Certification
- ISO 13485 Certification
- CAP Biorepository Accreditation
- State of MD Pharmacy License
- CLIA Assays
Fully Compliant with FDA, EMA and MHRA Standards
- FDA 21 CFR part 11 compliant biospecimen inventory system
- Trained on General Data Protection Regulation
- Self-certified member of the EU-US and Swiss-US Privacy Shield Framework
Human Subject Compliance
- Health Insurance Portability and Accountability Act of 1996 (HIPAA)
- 21 CFR 50 Protection of Human Rights
- 21 CFR 56 Institutional Review Boards
- IRB/Ethics Compliance
- Informed Consent
Site and lab-specific regulatory information
Precision for Medicine, GmbH, Berlin, Germany
- PFM GmbH is accredited according to ISO 17025:2018
ISO 17025 Accreditation with Flexible Scope, Category II:
List of Accredited Methods: