Who We Are
A partnership built to bridge the gap between MENA pharmaceutical manufacturing excellence and US regulatory compliance.
Our Foundation
[COMPANY NAME] was founded on a simple but powerful observation: the Middle East and North Africa region is home to pharmaceutical manufacturers with significant production capabilities and deep technical expertise — yet many face substantial barriers when seeking to access the US market.
These barriers are rarely about manufacturing quality. They are about regulatory navigation — understanding the FDA's expectations, preparing documentation to US standards, and maintaining the ongoing compliance infrastructure that sustained market access requires.
Our partnership brings together a US-based regulatory expert with decades of experience in FDA compliance, GMP certification, and quality systems — and a MENA-based pharmaceutical professional with deep roots in the region's manufacturing landscape and regulatory environment.
Together, we offer what neither could provide alone: a consulting firm that truly understands both sides of the equation. We speak both languages — literally and professionally — and we are committed to building lasting partnerships with manufacturers who are serious about US market entry.
Leadership
Two complementary perspectives united by a shared commitment to pharmaceutical excellence.
Managing Partner, US Operations
A seasoned regulatory and quality professional with a proven track record across the pharmaceutical and life sciences industries. Jared has helped over 200 clients achieve and maintain regulatory certifications, bringing deep expertise in FDA compliance, GMP systems, and quality management.
His specializations include Computer Software Assurance and Pharmaceutical Validation Management — critical capabilities for modern pharmaceutical manufacturing environments.
Certifications
Managing Partner, MENA Operations
A pharmaceutical industry professional with extensive experience in contract manufacturing operations across the Middle East and North Africa region. [PARTNER NAME] brings deep relationships with regional regulatory agencies and an intimate understanding of local manufacturing practices.
Their expertise in navigating regional regulatory frameworks — combined with firsthand knowledge of pharmaceutical production at scale — makes them the ideal partner for bridging MENA manufacturing capabilities with international market requirements.
Credentials
Professional Standards
Our team holds leading industry certifications, ensuring the highest level of professional competence in every engagement.
Certified expertise in pharmaceutical regulatory affairs and agency interactions
Qualified auditor for food safety and quality management systems
Certified Manager of Quality and Organizational Excellence
Project Management Professional certification for disciplined execution
Certified Pharmaceutical GMP Professional for manufacturing compliance
Specialized expertise in FDA's risk-based approach to software validation
Certified in pharmaceutical validation processes, equipment, and systems
A proven record of helping organizations achieve regulatory compliance
Global Reach
Strategic positioning across four key markets allows us to serve clients where they operate and where they want to grow.
Headquarters & FDA liaison operations
Manufacturing partnerships & local regulatory expertise
SFDA alignment & Vision 2030 pharma sector
EDA regulatory expertise & generic manufacturing
Work With Us
Whether you are exploring US market entry for the first time or looking for a regulatory partner who understands your region — we are here to help.
Or email us at info@[domain].com