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.
Certified by the Leading Regulatory Bodies Worldwide
FDA
REGISTERED
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
