Global Oversight , Regulatory Compliance , Inspection Readiness
Quality Assurance (QA) is at the core of successful clinical development. Our services provide end-to-end quality oversight across Phase I–IV trials and bioequivalence studies, ensuring compliance with ICH-GCP and the requirements of regulatory authorities worldwide.
Whether you are a sponsor, CRO, site, or vendor, we help you build confidence in your clinical programs by safeguarding data integrity, patient safety, and regulatory compliance.
Our Global QA Capabilities
Worldwide Coverage : QA support across North America, Europe, Asia-Pacific, and emerging markets.
Multi-Phase Expertise : From first-in-human studies through late-phase and post-marketing trials.
Regulatory Alignment : Deep understanding of FDA, EMA, MHRA, Health Canada, PMDA (Japan), TGA (Australia), and other health authorities.
Flexible Delivery : On-site, remote, or hybrid audits and inspections tailored to global study needs.
Our QA Service Portfolio
Risk-Based Auditing:
Sponsor systems and quality processes
Clinical trial sites (Phase I units, hospitals, specialty centers)
Bioequivalence and pharmacology study units
Central and specialty laboratories
Pharmacovigilance and safety reporting activities
Third-party vendors and CROs
Systemic gap assessments and root cause analysis
Trial Master File (TMF), Site & CRO Audits
eTMF and paper TMF compliance reviews
Phase I units and clinical site audits (screening, dosing, monitoring, data capture)
Vendor qualification and oversight audits
CRO process evaluations and GCP adherence checks
Mock Inspections & Inspection Readiness
Simulated regulatory inspections (FDA, EMA, MHRA, etc.)
Inspection readiness checklists, timelines, and gap closure plans
Staff training, role-specific coaching, and interview preparation
Documentation review and inspection war rooms (on-site/virtual)
SOP & Policy Development
SOP creation, review, and harmonization
Global regulatory alignment and best practices integration
Controlled document lifecycle management
Targeted SOP training for teams and vendors
Regulatory Inspection Support
On-site or virtual inspection support
Real-time stakeholder coordination and communication
Document retrieval and submission management
Query handling and immediate issue resolution
Post-inspection follow-up and strategy planning
Corrective and Preventive Action (CAPA) Management
Root cause analysis with industry-standard methodologies
CAPA plan development, tracking, and closure
Effectiveness checks and verification
Continuous process improvement
Why Partner With Us:
Comprehensive Global QA Coverage
Supporting Phase I–IV studies and bioequivalence programs worldwide
Regulatory Authority Expertise
Experienced in FDA, EMA, MHRA, PMDA, TGA, Health Canada, and local agency expectations.
Integrated QA Approach
From audits and inspection readiness to CAPA management, ensuring continuous compliance.
Scalable Engagements
Flexible models tailored to sponsors, CROs, sites, and vendors
Proven Success
A track record of helping clients achieve inspection readiness and maintain long-term compliance.
