Strategic Consulting
Comprehensive strategic consulting for international pharmaceutical manufacturers navigating the complexities of US regulatory compliance. From initial market analysis through post-approval maintenance.
Discuss Your StrategyOur Expertise
We provide strategic regulatory consulting for international pharmaceutical manufacturers seeking to enter or expand within the US market. Our team serves as your dedicated regulatory partner, guiding every decision from initial feasibility through successful market entry.
Our approach combines deep knowledge of FDA regulatory frameworks with firsthand understanding of manufacturing practices in the Middle East and North Africa. This dual expertise allows us to anticipate challenges, streamline submissions, and accelerate your path to compliance.
Whether you are a contract manufacturer exploring US market potential, an established producer seeking new product approvals, or a pharmaceutical company requiring strategic guidance on regulatory pathways — we provide the expertise and hands-on support to make it happen.
Market Entry Strategy
Comprehensive assessment of your products, manufacturing capabilities, and competitive positioning for the US market
Regulatory Pathway Mapping
Identification of the optimal regulatory route — NDA, ANDA, 505(b)(2), OTC monograph, or other applicable pathways
Dossier Preparation
Complete preparation of CTD/eCTD submissions, including Module 3 quality documentation and regional requirements
FDA Liaison
Direct communication management with FDA reviewers, including pre-submission meetings and response to information requests
Our Methodology
A proven five-phase methodology that takes international manufacturers from market evaluation to sustained US regulatory compliance.
We evaluate your product portfolio, manufacturing capabilities, and competitive landscape to determine market viability. This includes regulatory gap analysis, cost-benefit assessment, and timeline projections for US market entry.
Based on your product type, existing data, and commercial objectives, we identify the optimal FDA submission pathway. Whether NDA, ANDA, 505(b)(2), or OTC monograph — we map the most efficient route to approval.
We prepare or review all required regulatory documentation, including CTD/eCTD formatted submissions, quality modules, stability data packages, and manufacturing process descriptions — ensuring every element meets FDA expectations.
We manage the complete submission process and serve as your regulatory liaison with the FDA. This includes pre-submission meeting requests, formal submissions, and managing all agency correspondence and information requests.
Approval is the beginning, not the end. We provide ongoing support for annual reporting, post-marketing commitments, variation management, and inspection readiness — ensuring your US market access is maintained long-term.
Regional Expertise
Deep regional knowledge combined with US regulatory expertise — a rare combination that accelerates your path to market.
Intimate knowledge of the Syrian pharmaceutical manufacturing landscape, including established production capabilities and quality systems. We understand the unique challenges and opportunities for Syrian manufacturers seeking international market access.
Our team navigates the intersection of local regulatory requirements and FDA expectations, helping bridge documentation standards and quality system gaps.
Deep understanding of Saudi Arabia's evolving pharmaceutical regulatory framework under SFDA, including Vision 2030 initiatives driving domestic manufacturing growth. We help Saudi manufacturers leverage their SFDA compliance as a foundation for FDA readiness.
Our expertise in SFDA-to-FDA regulatory alignment helps identify areas of existing compliance and focus resources on the specific gaps that matter.
Comprehensive understanding of Egypt's pharmaceutical sector, including EDA regulatory requirements and the country's position as a leading generic drug manufacturer in the MENA region. We help Egyptian manufacturers translate their production scale into US market opportunity.
Our knowledge of EDA-to-FDA regulatory crosswalks accelerates the transition from regional compliance to US market readiness.
Our team operates fluently in both English and Arabic, eliminating the communication barriers that often slow regulatory projects. From translating technical documentation to facilitating discussions between your manufacturing teams and US regulatory authorities, our bilingual capability ensures nothing is lost in translation — literally or figuratively.
Start Your Journey
Contact our regulatory strategy team for a confidential discussion of your market entry objectives. We'll assess your current position and outline a clear pathway to US regulatory compliance.
Or email us at info@[domain].com