Quality Assurance &
Compliance

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Quality systems should do more than meet regulatory requirements - they should strengthen the entire organization.
GSAP helps organizations build, maintain, and optimize compliant quality frameworks that improve operational performance, support inspection readiness, and drive continuous improvement across the product lifecycle

Iris next to production line

Our services include:

  • Inspection Readiness (MOH & FDA)
  • Mock FDA Inspections
  • Quality Systems Development, Assessment and Remediation
  • Eudralex Annex 1 gap assessment
  • Contamination Control Strategy (CCS) establishment
  • Data Integrity auditing and Remediation
  • Process validation
  • Cleaning validation
  • Cross Contamination in shared facilities Risk assessment
  • QA AI&ML Compliance Services
  • Internal Audits
  • Root Cause Investigations and CAPA Remediation
  • Third-party GMP and GDP Compliance Auditing
  • Risk management according to ICH Q9
  • Routine management of QMS elements – Deviations, CAPA, Change management, Supplier qualification
  • Shipping and storage quality assurance
  • Quality Control (QC) Laboratory Services:
    • Support for establishment of new laboratories
    • Laboratory QMS establishment and implementation
    • Out of Specifications (OOS) assessment and remediation
    • Analytical and bioanalytical methods development and validation – planning and oversight, protocols and reports writing
    • Laboratory glassware cleaning validation
  • Phase-Appropriate QMS Establishment & Remediation
    • Designing, building, and deploying lean, phase appropriate Quality Management Systems tailored for early-stage startups and academic spin-offs
    • Comprehensive evaluation of existing quality frameworks against global regulatory standards (FDA, EMA, ICH, PIC/S) across GxP domains (GMP, GLP, GCP) to identify compliance risks and build prioritized remediation roadmaps