Quality Strategy and Compliance

Expert services to support quality compliance in research and development.

Quality Compliance Services

Quality compliance in clinical trials ensures adherence to regulatory, ethical, and scientific standards to protect patient safety, maintain data integrity, and support regulatory approval. It involves GCP-aligned systems, documentation, training, auditing, and risk mitigation across the trial lifecycle.

Versiti Clinical Trial Services provides tailored quality systems and validation support to biopharma, medical device, and diagnostics companies of all sizes.

 

Core Services

  • GxP Quality Systems: Compliant with FDA, EMA, and global standards (GCP, GMP, GLP, CLIA, CAP)
  • GxP Auditing: Risk-based audits for clinical, manufacturing, and non-clinical operations
  • Validation Support: Full-scope validation for processes, equipment, software, and methods
  • Remediation: CAPA development, FDA 483 response, site rescue, and system overhaul
  • Training Programs: 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

GxP Compliance

Versiti’s experts support global compliance across regulated industries and development stages, including:

  • Gap analyses and continuous compliance monitoring
  • Quality systems tailored to drug, biologic, diagnostic, device, and combo product development
  • Expertise in FDA, ISO, ICH, USP, CLIA, and European/Canadian directives

Applicable Regulations:

  • Clinical Compliance: 21 CFR Parts 50, 54, 56, 312, 314, 361
  • Manufacturing Standards: 21 CFR Parts 210, 211, 111, 820, 600, 601, 610
  • Non-Clinical Research: 21 CFR Part 58
  • Electronic Records: 21 CFR Part 11
  • ISO Standards: 13485, 14155, 14971, 22716, 9000s, 15189, 17025
  • ICH Guidelines: Q7A, E6, E2A
  • Others: USP 797 (Compounding Pharmacy), SOR-98-282, 
  • EU Directives: 2001/20/EC, 2005/28/EC
 

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

Validation Services

Customized validation strategies aligned with your product lifecycle.

  • Validation Master Plans (VMP)
  • Equipment, utility, and software qualification
  • Analytical and microbiological method validation
  • IQ/OQ/PQ protocol development and execution
 
 

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 offers custom and ready-to-use modules for teams at all levels.

Topics Include:

  • Regulatory pathways (IND, NDA, IDE, PMA, etc.)
  • GCP, GMP, GLP, IRB, and CAPA training
  • FDA audit prep and inspection readiness
  • Quality systems for compounding pharmacies and dietary supplements
 
 

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

 
Kimberley Buytaert-Hoefen, Ph.D

Chief Operating Officer

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 validation and quality services can support your next milestone.

Speak to a Quality Expert
 
Regulatory Guidance & Global Filings
Versiti offers expert regulatory strategy and global filing support to accelerate approvals, reduce costs, and ensure compliance worldwide.
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Technical & Scientific Writing
Versiti Clinical Trial Services offers expert technical and scientific writing services, ensuring accuracy and clarity in regulatory submissions, clinical trial documentation and more.
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Study Design & Site Selection Services
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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