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About APS

About APS

Your trusted resource for a full range of preclinical services.

Experience APS

Compliance & Accreditations

Accredited and Compliant, APS is Dedicated to Quality and Regulatory Compliance

Quality Assurance
Accurate documentation and data integrity are our highest priorities. APS has an independent quality assurance staff involved in maintaining compliance to ISO 17025 and FDA Good Laboratory Practices requirements. Our team participates in all study designs and subsequently performs multiple audits during each study to assure data integrity.

GLP Compliance  
A GLP compliant laboratory, APS meets or exceeds FDA standards for data integrity and documentation practices. We also have the necessary organization, staff, operating procedures and reporting standards to comply with FDA and International GLP regulations.

Our studies are routinely submitted to the FDA in 510(k), IDE, IND, and PMA applications. Furthermore, our team of experienced GLP auditors are accustomed to diligently monitoring studies to ensure they’re run in a controlled, well-documented manner while delivering the utmost integrity of data.

ISO 17025 accredited
APS operates a comprehensive quality management system accredited to ISO 17025 for identification of client needs, test selection, test validation, test documentation and reporting of results. In addition, biocompatibility tests are included under our scope of accreditation.

APS ISO 17025 Certification

APS ISO 17025 Scope

 

Laboratory Quality Standards

  • FDA 21 CFR Part 58 - Good Laboratory Practice (GLP)
  • ISO/IEC 17025 - Requirements for the Competence of Testing and Calibration Laboratories
  • Public Health Services (PHS) 42 USC Chap 16B - Contracts for Scientific and Technological Research

Animal Welfare Standards

  • USDA Class R Facility License
  • AAALAC Accredited (Association for Assessment and Accreditation of Laboratory Animal Care

Radiation Certification

  • Radioactive Materials License

Take a look inside at the capabilities that APS has to offer...

American Preclinical Services (APS) is a State of the Art, ISO 17025 accredited, AAALAC accredited, USDA registered and GLP compliant Contract Research Organization (CRO) located in Minneapolis, MN.

We are a comprehensive CRO whose catalogue includes ISO10993, USP, USP, JMHLW, custom biocompatibility testing, interventional, surgical, toxicology, pharmacology, pain, cadaver and bioskills, model development and complete pathology services.

Whether your company is a startup or an established industry leader, APS’ experienced staff is uniquely qualified to tackle your project and meet your in-vivo and in-vitro preclinical research needs in a timely fashion. more