Regulatory and Quality

Regulatory Affairs

Our regulatory team has vast 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 provide regulatory support solutions including;

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

Quality Assurance

Almac Diagnostics is accredited by:

  • UKAS to ISO17025 (accreditation number 2740) & ISO15189
  • US Clinical Laboratory Improvement Amendments (CLIA)
  • College of American Pathologists (CAP)
  • New York State (CLEP Permit)

We are licensed by the Human Tissue Act and hold individual US State licenses for Florida, California and Pennsylvania.

We are also ISO13485 certified for the design, development & manufacture of in vitro diagnostic nucleic acid technique based assays for gene mutation and expression analysis and we comply with GLP, GCP and GCLP.

The growing importance of biomarkers in personalised medicine means that our clinical testing laboratories need to meet the highest standards of quality and safety. Almac Diagnostics’ regulatory experience and quality accreditations demonstrate that we meet these standards and provides confidence to our clients.

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