Compliance and Validation Services

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Validation Audits


Bioavailability and Bioequivalence Studies, and Contract/Clinical Research Organizations

In support of audits for bioavailability and bioequivalence studies, as well as for Contract Research Organizations, PharmaSys provides a wide range of services and support:

  • Third party audits of clinical study laboratory data for bioavailability and bioequivalence studies in support of Abbreviated New Drug Applications (ANDAs) and New Drug Applications (NDAs).
  • Consulting services to develop clinical study laboratory data for bioavailability and bioequivalence studies, as well as assistance in the design and analysis of bioavailability and bioequivalence studies in support of Abbreviated New Drug Applications (ANDAs) and New Drug Application (NDAs).
  • Third party audits of clinical and preclinical test facilities for adherence to ICH E6 Good Clinical Practices and US FDA and OECD Principles of Good Laboratory Practice.
  • Third party audit services for clinical and laboratory studies to support EEA and EU Marketing Authorization Applications (MAAs).
  • Consulting services to help companies set-up studies to support EEA and EU Marketing Authorization Applications (MAAs).
  • Consulting services and SOPs for clinical operations, clinical data management and clinical trial management services for sponsors and contract/clinical research organizations.
  • Watchdog quality services for small research-driven biopharma companies, as well as SOPs for clinical operations, clinical data management and clinical trial management services for sponsors and contract research organizations.
  • Audit and watchdog quality services for clinical operations, clinical data management and clinical trial management services for sponsors and clinical research organizations.


If you are interested in finding out more about PharmaSys' world-class offerings, complete and submit the form provided below. You will be contacted to discuss your needs and provided with information about how PharmaSys can help you achieve your compliance and validation goals.


 
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