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QA & Compliance

 

BioPoint understands how important it is to your company that your quality systems work efficiently and comply with the current domestic and international regulatory requirements. As the regulatory landscape around clinical development evolves, it is vital for our clients to meet regulatory expectations and still remain competitive in the marketplace.

Why BioPoint?

The effectiveness of your clinical quality process will ultimately determine the success of your clinical trials and your regulatory agency inspection readiness. Thus, your clinical quality process is a key component in building a solid reputation within your organization and with regulatory authorities.

BioPoint has a team of experienced and knowledgeable quality assurance experts that can help you create a clinical quality process and system, or, objectively assess existing clinical quality systems. Our QA team can ensure your clinical quality system meets global quality and compliance requirements.

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QA & Compliance Consulting Services

  • All aspects of GCP, GMP, and GLP auditing
  • Pharmacovigilance audits
  • Mock Audits & Inspection Readiness
  • Clinical Study Report review and auditing
  • Computer Systems Validation
  • Strategic Process Development
  • SOP and Protocol design, development, and review
  • CAPA development