GxP Compliance Services for Life Sciences in UAE
Comprehensive GMP, GLP, GCP, and GDP compliance support for pharmaceutical, biotech, and clinical research organizations across the UAE and GCC. From gap assessments to audit readiness, we build lasting compliance.
20+
Years Experience
100%
Audit Success
FDA/EMA
Aligned Programs
ICH Q10
QMS Framework
Understanding GxP Regulations
GxP encompasses all "Good Practice" regulations governing the pharmaceutical and life sciences industries. Each addresses specific aspects of the product lifecycle.
Good Manufacturing Practice
Manufacturing and quality control requirements for pharmaceutical, biotech, and medical device production. Ensures products are consistently produced and controlled to quality standards.
Good Laboratory Practice
Standards for non-clinical laboratory studies supporting product safety. Ensures data integrity, reproducibility, and regulatory acceptance of preclinical studies.
Good Clinical Practice
International ethical and scientific quality standard for clinical trials. Protects subjects' rights and ensures clinical data credibility.
Good Distribution Practice
Requirements for proper storage, transportation, and distribution of pharmaceutical products. Maintains product integrity throughout the supply chain.
Good Pharmacovigilance Practice
Guidelines for monitoring safety of authorized medicines. Ensures timely detection and reporting of adverse drug reactions.
Good Documentation Practice
Standards for creating, maintaining, and archiving records. Foundation for data integrity and regulatory compliance across all GxP areas.
Our GxP Compliance Services
Comprehensive support for building and maintaining GxP compliance across your organization—from framework implementation to ongoing maintenance.
GxP Framework Implementation
Establish robust GMP, GLP, GCP, and GDP frameworks tailored to your operations, regulatory environment, and business objectives.
Quality Management System Support
QMS development, gap analysis, optimization, and continuous improvement programs aligned with ICH Q10 and ISO standards.
SOP Development & Optimization
Standard operating procedures that are practical, compliant, and maintainable—designed for real-world implementation.
Compliance Training Programs
Role-based training curricula for GxP awareness, building a compliance culture from floor operators to leadership.
Audit Preparation & Mock Inspections
Mock FDA, EMA, and MHRA inspections, readiness assessments, and hands-on support during regulatory audits.
CAPA Management
Corrective and Preventive Action programs that identify root causes and drive lasting operational improvements.
Vendor Qualification & Auditing
Supplier qualification programs, vendor audits, and ongoing oversight to ensure supply chain compliance.
Process Validation Support
Stage 1-3 process validation lifecycle support including protocol development, execution, and continued process verification.
Our GxP Implementation Methodology
A systematic six-phase approach to achieving and maintaining GxP compliance that balances regulatory rigor with operational practicality.
Gap Assessment & Current State Analysis
We conduct a comprehensive evaluation of your existing quality systems, SOPs, and operational practices against applicable GxP requirements. This includes reviewing documentation, interviewing key personnel, and observing operations to identify compliance gaps and improvement opportunities.
Risk Assessment & Prioritization
Using ICH Q9 risk management principles, we categorize identified gaps by severity and potential impact on product quality and patient safety. This creates a prioritized remediation roadmap that addresses critical issues first while managing resources effectively.
Framework Design & Documentation
Development of quality management framework including policies, procedures, and work instructions. We create practical, implementable documentation that meets regulatory requirements without overburdening your operations.
Implementation & Training
Hands-on support during framework rollout, including SOP implementation, system configuration, and comprehensive training programs. We ensure your team understands not just what to do, but why—building lasting compliance culture.
Verification & Qualification
Formal verification that implemented systems and processes meet requirements through audits, testing, and qualification activities. We create inspection-ready documentation packages demonstrating compliance.
Ongoing Compliance Maintenance
Establishing periodic review schedules, change control procedures, CAPA programs, and continuous monitoring to maintain compliance as regulations evolve. Long-term partnership to sustain your quality system.
Industries We Serve
Our GxP expertise spans the full life sciences spectrum, with tailored solutions for each industry's unique requirements.
Pharmaceutical Manufacturing
GMP compliance for API manufacturing, formulation, packaging, and quality control laboratories. Support for FDA, EMA, and WHO prequalification requirements.
Biotech & Biologics
Specialized GMP support for cell culture, fermentation, purification, and aseptic processing. Compliance with ICH Q5 biological product guidelines.
Clinical Research Organizations
GCP compliance for clinical trial conduct, data management, and regulatory submissions. Support for investigator sites and sponsor oversight.
Medical Device Companies
Quality system requirements under FDA 21 CFR Part 820 and ISO 13485. Design controls, production validation, and post-market surveillance.
Contract Manufacturers (CMOs)
Multi-client GMP compliance, technology transfer support, and quality agreement development. Audit readiness for client and regulatory inspections.
Distribution & Logistics
GDP compliance for pharmaceutical wholesalers, cold chain management, and supply chain integrity. Qualification of storage and transport conditions.
Frequently Asked Questions About GxP Compliance
Expert answers to common questions about GMP, GLP, GCP, and regulatory compliance.
Why GxP Compliance Matters for UAE Life Sciences
GxP regulations form the foundation of quality and safety in the pharmaceutical, biotech, and medical device industries. For companies operating in the UAE and GCC, robust GxP compliance is not just a regulatory requirement—it's a competitive advantage that enables access to global markets and builds trust with healthcare providers and patients.
The UAE's strategic position as a regional pharmaceutical hub means companies must navigate multiple regulatory frameworks. Local MOHAP requirements align with international GMP standards, while export markets demand compliance with FDA, EMA, or WHO prequalification standards. A well-designed GxP program addresses these overlapping requirements efficiently, avoiding duplication while ensuring comprehensive coverage.
Our approach combines deep regulatory knowledge with practical operational experience. We understand that compliance must work in the real world—documentation that sits unused in binders doesn't protect patients or satisfy inspectors. Neural Architects builds GxP programs that your team can actually follow, creating genuine quality culture rather than checkbox compliance.
Ready to Achieve Compliance Excellence?
Whether you're facing an audit, implementing new systems, or building AI solutions for regulated environments—we're here to help.
Free initial consultation • No obligation • UAE & GCC focused