The Assurance of Regulatory Compliance

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.

The Assurance of Regulatory Compliance

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.
Recognized Mature Quality Management Systems
  • 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

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: