Quality Strategy and Compliance

Expert services to support quality compliance in research and development.

Quality Compliance Services

Quality compliance ensures adherence to regulatory, ethical, and scientific standards to protect patient safety, and maintain data integrity throughout every phase of a product’s life cycle or laboratory service.

Whether you are sponsor of  a medical device, IVD, pharmaceutical or biologic, or you are a clinical diagnostic laboratory, Versiti Clinical Trial Services has the expertise to answer your quality needs with a broad spectrum of services, including:

  • Auditing
  • Remediation Services
  • Regulatory and Compliance Training
  • CMC Development and Oversight
  • Supplier Management
  • Clinical Trial Monitoring
 

Core Services

  • Quality system development: in compliance with regional regulations and industry standards and guidelines
  • Risk-based quality system audits: for clinical, manufacturing, and laboratory operations
  • Remediation: CAPA development, FDA 483 response, site rescue, and system overhaul
  • Training programs: including custom and off-the-shelf training for regulatory, quality, and clinical teams
  • CMC Development: Integrated support for product development, formulation, and regulatory filings
  • Supplier Management: Performance tracking, risk mitigation, and compliance monitoring for vendors


Regulatory Compliance

Versiti has the expertise to ensure your quality system is compliant with regional regulations in key markets such as the USA and EU , and  in accordance with industry standards and guidelines, including:

  • GxPs
  • ICH guidelines
  • Industry standards (ISO, IEC, USP, ANSI/AAMI, etc.)
  • CAP
  • CLIA
 

Auditing Services

Good Clinical Practice (GCP) Audits:

  • Phase I facility audits, SOP reviews, SAE database evaluations
  • PI/staff training and IRB documentation assessments

Good Manufacturing Practice (GMP) Audits:

  • Site/supplier audits, mock FDA inspections, PAI readiness assessments
  • Validation, complaint handling, CAPA, and manufacturing process reviews

Good Laboratory Practice (GLP) Audits:

  • Facility and data integrity checks, SOP compliance, sample handling assessments
 

Remediation Services

Support to resolve quality issues and regulatory findings.

  • CAPA development and effectiveness checks
  • FDA 483 and warning letter response
  • Quality system upgrades and root cause analysis
  • Site recovery and tailored training

Regulatory & Compliance Training

Versiti Clinical Trial Services offers custom and ready-to-use modules for teams at all levels.

Topics Include:

  • Quality System requirements
  • Marketing Authorization Submissions
  • Clinical trial applications
  • GxP Training
  • FDA audit prep and inspection readiness
 
 

CMC Development & Supplier Oversight

Integrated Chemistry, Manufacturing, and Controls (CMC) services to accelerate development.

CMC Services:

  • Preformulation/formulation support for NCEs, biosimilars, generics, etc.
  • Analytical method development and validation
  • eCTD and regulatory submission prep (IND/CTA/IMPD/NDA/ANDA)
  • Direct FDA/EMA engagement

Supplier Management:

  • Vendor qualification and performance tracking
  • Supply risk mitigation and quality system alignment

Our Experts

 
Eric English, MS, CBA, RAC

Director RA/QA Services

 
Maritza Ward, RAC

RA/QA Advisor

 
Ariana Jones

Senior Analyst, RA/QA Services

Partner with Versiti Clinical Trial Services

Ensure your clinical development is built on a foundation of quality, compliance, and confidence. Contact us today to discuss how our quality services can support your next milestone.

Speak to a Quality Expert
 
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Versiti offers expert regulatory strategy and global filing support to accelerate approvals, reduce costs, and ensure compliance worldwide.
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Optimize your Clinical Trial Study Design with expert site selection and monitoring services tailored to ensure trial success from start to finish.
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