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Precision for Medicine
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Precision Wins Fierce CRO Award for Innovative Solutions in Drug Development

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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
  • ICH E6(R2) Good Clinical Practices (GCP)
  • Good Laboratory Practices (GLP)
  • UK Human Tissue Authority 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:

 

 

 

PDAC KRAS Assay GSPR Compliance Statement:

 

Information regarding the PFM GmbH Complaint Process can be found here.

A Guideline for Collecting, Packing and Sending Samples for Diagnostic Testing at PFM GmbH can be found here.

Informationen zum Beschwerdeprozeß der PFM GmbH sind hier zu finden.

Ein Leitfaden zum Sammeln, Verpacken und Versenden von Proben für diagnostische Tests durch die PFM GmbH ist hier zu finden.