International Pharmaceutical Consulting

Navigating FDA
Compliance
for Global Markets

Expert regulatory consulting for pharmaceutical manufacturers seeking FDA registration, GMP certification, and ISO compliance across the Middle East and beyond.

Request Consultation +1-XXX-XXX-XXXX

Our Expertise

Regulatory & Compliance Services

Comprehensive consulting services designed to navigate the most demanding regulatory frameworks in the world.

FDA Registration

Facility Registration & Drug Listing

Navigate the complex FDA registration process for foreign pharmaceutical manufacturers. US Agent setup, facility registration, and ongoing compliance management.

GMP Certification

Current Good Manufacturing Practice

Achieve and maintain cGMP compliance for pharmaceutical manufacturing. Gap assessments, quality systems development, and FDA inspection readiness.

ISO Standards

Quality, Environmental & Safety Management

ISO 9001, ISO 14001, ISO 13485, and ISO 22000 certification readiness. Build management systems that meet international standards.

Regulatory Strategy

US Market Entry & Compliance Pathways

End-to-end regulatory strategy for international manufacturers entering the US pharmaceutical market. Pathway mapping, dossier preparation, and agency liaison.

International Reach

Bridging Middle Eastern Manufacturing to Global Markets

Our team combines deep US regulatory expertise with on-the-ground knowledge across Syria, Saudi Arabia, and Egypt. We understand both the FDA's exacting standards and the unique challenges facing manufacturers in the MENA region.

Local regulatory relationships in Syria, Saudi Arabia, and Egypt

US-based FDA expertise with proven registration success

Bilingual consulting in English and Arabic

Contract manufacturing expertise for pharmaceutical products

United States

FDA & Regulatory HQ

Syria

Manufacturing Partner

Saudi Arabia

Regional Operations

Egypt

Regional Operations

Why Choose Us

The Standard of Excellence

FDA compliance demands the highest level of expertise. Our consultants bring the credentials, experience, and international perspective required to succeed.

Deep Regulatory Knowledge

Certified professionals with extensive experience in 21 CFR Part 207, 210/211, and international GMP standards. We speak the language of regulators.

Cross-Border Expertise

We bridge the gap between MENA manufacturing operations and US regulatory requirements, with relationships on both sides of the equation.

Bilingual Partnership

Full consulting services in English and Arabic. Our team works directly with local staff, management, and regulatory authorities in their preferred language.

Leadership

Expert Consulting Team

Our leadership combines US regulatory credentials with deep regional industry knowledge.

JC

Jared Clark

Managing Partner — US Operations

RAC (Regulatory Affairs Certification)

CFSQA (Certified Food Safety & Quality Auditor)

CMQ/OE, PMP, CPGP Certified

200+ clients certified worldwide

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[PARTNER NAME]

Managing Partner — MENA Operations

[PARTNER CREDENTIAL 1]

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Pharmaceutical contract manufacturing expertise

Regional regulatory agency relationships

Get Started

Ready to Enter the US Market?

Schedule a confidential consultation with our regulatory experts. We'll assess your current compliance status, identify the optimal pathway, and outline a clear roadmap to FDA registration.

Request Consultation Call +1-XXX-XXX-XXXX

Or email us at info@[domain].com