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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: