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

Regulatory Information and Accreditations

Precision's QMS, regulatory, and compliance standards

Recognized Quality Management Systems, Licenses, and Accreditations

Fully Compliant with FDA, EMA and MHRA Standards

Human Subject Compliance

Site and lab-specific regulatory information

Precision for Medicine, GmbH, Berlin, Germany

ISO 17025 Accreditation with Flexible Scope, Category II:

List of Accredited Methods:

World class standards & certifications