Regulatory and Quality Proficiency

Quality Assurance

The growing importance of biomarkers in precision medicine means that our clinical testing laboratories also need to meet the highest standards of quality and safety. Almac Diagnostics’ quality accreditations demonstrate that we meet these standards, providing complete confidence to our clients.

 

Laboratory Accreditations:

  • CLIA (US Clinical Laboratory Improvement Amendments)
  • CAP (College of American Pathologists).
  • Human Tissue Act UK (HTA License).
  • US State Licences: New York (CLEP Permit), Florida, California, Pennsylvania and Maryland.
  • ISO 15189 and ISO 17025

Laboratory QMS:

  • We comply with GLP, GCP and GCLP.

Manufacturing Certifications:

  • ISO 13485

Regulatory Affairs

Our regulatory team has significant experience in working with regulatory agencies through our internal diagnostic pipeline as well as with our pharma partners in joint regulatory meetings. We currently manage regulatory plans for companion diagnostic tests in multiple global regions including USA, Canada, Europe, Japan and China.

We have the regulatory expertise required to help pharma and biotech clients navigate the regulatory landscape in key global territories. We currently have over 30 regulatory staff in total, of which 10 directly work in Multiplex CDx development.

We provide regulatory support solutions including:

  • Global regulatory strategies for CDx Development
  • CDx and IVD pre-submissions
  • IDE submissions
  • EU device & performance evaluation registration
  • Device classification assistance
  • Analytical and Clinical protocol design
  • Regulatory submissions
  • Regulatory agency liaison
  • Medical device reporting
  • Post-market support 

Regulatory Framework

Diagnostics Quality

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