Regulatory Compliance
Across the breadth of Cogenics’ service portfolio, we provide support for all levels of regulatory compliance. Cogenics operates facilities capable of generating the highest quality data in support of clinical trials and clinical diagnostics. Cogenics’ facilities use a quality program that incorporates components of GCP (FDA/ICH), GLP (FDA/OECD), GMP and CLIA regulations as they apply to services offered. Services are developed and provided based on client and regulatory requirements within the framework of the platform and project needs.

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Regulatory services are designed to support both preclinical and clinical needs, with full adherence to relevant regulations and guidelines including CFR Title 21 Part 58 for GLP, CFR Title 21 Part 211 for GMP, and CFR Title 21 Part 50 and ICH E6 for GCP. CLIA services meet the needs of physicians who wish to order pharmacogenetic tests to aid in medical treatment. Tests can be developed, validated, and offered through Cogenics. The hallmarks of Cogenics’ various service levels include:

• Research
  • Suitable for everyday applications
  • Performed under documented procedures

• Regulatory (relevant GCPs, GLPs, and/or GMPs):
  Required for client regulatory submissions
  
  
  • Performed under applicable regulatory requirements (GCP/ICH, GLP, GMP)
  • Voluntary hosting of >100 customer audits to ensure quality of services
  • Experience completing >550 genotyping clinical trial projects
  • Experience completing >1,500 sequencing clinical trial projects
    
    
• CLIA Diagnostics
  Required when test results are returned to Physician or Patients (Direct-Access testing) for use in medical treatment or dosing decisions
  
  
• Performed in CLIA-certified facilities (non-waived, high complexity)
• Cogenics’ facilities experienced with over 8 years in CLIA testing