Regulatory Compliance

Navigating Regulations with Confidence

At Fahmy Consulting, we simplify complex regulatory frameworks so your business can focus on growth — not paperwork.
Our mission is to help organizations achieve, maintain, and demonstrate compliance with U.S. and international regulatory requirements through clear systems, practical documentation, and expert guidance.

Compliance is more than meeting regulations — it’s building trust, credibility, and resilience.

Our Regulatory Expertise

We provide end-to-end compliance consulting across multiple sectors — helping clients understand, implement, and sustain regulatory programs efficiently and effectively.

Our team supports compliance for:

  • FDA – Food & Drug Administration (U.S.)
  • EU MDR – European Union Medical Device Regulation
  • FSVP – Foreign Supplier Verification Program
  • GMP / GDP – Good Manufacturing & Distribution Practices
  • EUDR – European Deforestation Regulation
  • FSC / ESG / Sustainability Programs
  • Custom Regulatory Frameworks – tailored to your industry
Our Approach

We take a hands-on, system-based approach to regulatory compliance:

  • Assessment & Gap Analysis
    Identify compliance gaps, risks, and potential nonconformities.
  • Documentation Development
    Create or enhance SOPs, quality manuals, risk assessments, and traceability systems.
  • Training & Awareness
    Equip your team with the knowledge to maintain compliance daily.
  • Mock Audits & Inspection Readiness
    Simulate FDA or regulatory inspections to ensure real-world preparedness.
  • Continuous Support
    Ongoing advisory for regulatory updates, CAPA management, and recertification.

Our goal is not only compliance — it’s capability. We empower your team to sustain it.

Specialized Regulatory Areas
  • FDA Compliance
  • Medical devices, pharmaceuticals, dietary supplements, and food facilities
  • Registration, labeling, and submission requirements
  • Quality System Regulation (QSR 21 CFR Part 820)
  • 21 CFR Part 117 (Food Safety) and Part 210/211 (GMP)
  • EU MDR
  • Gap analysis and technical documentation review
  • Post-market surveillance systems
  • ISO 13485 alignment for medical device manufacturers
  • FSVP (Foreign Supplier Verification Program)
  • FDA compliance for U.S. food importers
  • Supplier qualification, verification records, and audit documentation
  • GMP / GDP
  • Process validation and traceability systems
  • Facility layout, hygiene, and production environment compliance
  • Internal audit and CAPA management
  • EUDR / ESG / Sustainability
  • Environmental due diligence and deforestation-free sourcing compliance
  • Integration with ISO 14001 and ESG performance systems
Deliverables You Receive
  • Customized Regulatory Compliance Manual
  • Comprehensive Risk & Mitigation Matrix
  • Full Compliance Documentation Set (SOPs, forms, records)
  • Training Certificates for your team
  • Mock Audit Report with findings and recommendations
Industries We Serve
  • Pharmaceuticals & Life Sciences
  • Food & Beverage
  • Packaging & Manufacturing
  • Maritime Operations
  • Import / Export & Distribution
  • Startups and SMEs entering regulated markets
  • ⚙️ Why Choose Fahmy Consulting
  • 25+ years of international experience in ISO, FDA, and EU compliance
  • Deep understanding of both U.S. and GCC regulatory frameworks
  • Custom documentation that aligns with real operations
  • Strong background in risk management and continuous improvement

We don’t just help you comply — we help you compete globally with confidence.