🇱🇧 Regulatory Affairs Services – Lebanon
REGULATORY NEXUS GLOBAL
Lebanon Regulatory Affairs Solutions for Pharmaceutical, Nutraceutical, Herbal and Cosmetic Products
REGULATORY NEXUS GLOBAL is a specialized scientific and regulatory division of Zoesoe Exports Pvt Ltd, providing professional regulatory affairs services and product registration support for Lebanon.
We assist pharmaceutical, nutraceutical, herbal, veterinary and cosmetic companies in navigating the Lebanese regulatory framework and successfully registering their products for the Lebanon market.
Our regulatory specialists provide complete regulatory documentation, dossier preparation and submission support aligned with Lebanese regulatory authority requirements.
Lebanon Regulatory Authority
Pharmaceutical products, medical products and cosmetics in Lebanon are regulated by the Ministry of Public Health Lebanon (MOPH).
The Ministry of Public Health is responsible for:
• Registration and approval of pharmaceutical products
• Evaluation of medicines for safety, quality and efficacy
• Licensing of pharmaceutical importers and distributors
• Regulation of cosmetics and healthcare products
• Monitoring drug safety and pharmacovigilance
REGULATORY NEXUS GLOBAL provides regulatory documentation and compliance support aligned with MOPH regulatory requirements.
Our Mission
To simplify Lebanon regulatory compliance and enable companies to successfully register and market their products in Lebanon through scientifically sound and compliant regulatory documentation.
Our Core Regulatory Services for Lebanon
Pharmaceutical Product Registration Dossiers
We prepare Lebanon-compliant pharmaceutical regulatory dossiers for submission to the Ministry of Public Health.
Our services include preparation of:
• Administrative documentation
• Product formulation and composition details
• Manufacturing process documentation
• Quality control specifications and analytical methods
• Stability study reports
• Certificate of Pharmaceutical Product (CPP) documentation
• GMP documentation
• Bioequivalence documentation (where required)
All dossiers are prepared according to Lebanese regulatory guidelines and international regulatory standards.
CTD Dossier Preparation
Lebanon accepts regulatory submissions based on the **Common Technical Document (CTD) format.
Our CTD services include preparation of:
• Module 1 – Administrative Information
• Module 2 – Quality Overall Summary (QOS)
• Module 3 – Quality / CMC Documentation
• Module 4 – Non-Clinical Study Reports
• Module 5 – Clinical / Bioequivalence Study Reports
Our regulatory experts ensure dossiers comply with ICH guidelines, WHO standards and Lebanon regulatory expectations.
Pharmaceutical Registration Process in Lebanon
The general process for pharmaceutical product registration in Lebanon includes:
Appointment of a local Lebanese agent or distributor.
Submission of regulatory dossier and legalized documentation to the Ministry of Public Health.
Technical evaluation of product quality, safety and efficacy.
Laboratory testing and regulatory review.
Approval and issuance of Marketing Authorization for Lebanon.
The registration process may take 6–12 months depending on product category and regulatory evaluation.
Regulatory Services for Multiple Product Categories in Lebanon
Pharmaceuticals
• Generic drug registration dossiers
• API documentation and DMF support
• Bioequivalence documentation
• CMC documentation
• Stability study documentation
• GMP compliance documentation
Nutraceuticals & Health Supplements
Lebanon has an increasing demand for health supplements and nutraceutical products.
Our services include:
• Product technical documentation
• Ingredient regulatory compliance verification
• Label compliance documentation
• Export regulatory documentation
Herbal & Traditional Medicine Products
Herbal and natural health products are widely used in Lebanon.
We provide regulatory documentation support including:
• Herbal product regulatory dossiers
• Traditional medicine documentation
• Ingredient safety documentation
• Export registration support
Cosmetics & Personal Care Products
Cosmetic products in Lebanon must comply with national safety and regulatory documentation requirements.
Our services include:
• Cosmetic product technical documentation
• Ingredient regulatory compliance verification
• Cosmetic product registration documentation
• Product safety documentation
Veterinary Products
• Veterinary drug regulatory dossiers
• Product technical documentation
• Export regulatory documentation
Additional Regulatory Support
REGULATORY NEXUS GLOBAL also provides:
• Technical scientific document writing
• Product development documentation
• Analytical method validation documentation (ICH Guidelines)
• Clinical trial and bioequivalence documentation
• Regulatory gap analysis
• Regulatory strategy planning
• Export registration support for Lebanon
Lebanon Market Entry Support
Our regulatory experts assist companies seeking to enter the Lebanese pharmaceutical and healthcare market through:
• Regulatory documentation preparation
• CTD-compliant dossier development
• MOPH regulatory submission support
• Import/export regulatory documentation
• Market entry regulatory consulting
Why Choose REGULATORY NEXUS GLOBAL
✔ Experienced regulatory affairs professionals
✔ Expertise in Lebanon regulatory requirements
✔ ICH-compliant regulatory documentation
✔ Support from product development to registration
✔ Reliable scientific documentation
✔ End-to-end regulatory solutions
About REGULATORY NEXUS GLOBAL
REGULATORY NEXUS GLOBAL operates as the scientific regulatory arm of Zoesoe Exports Pvt Ltd, providing global regulatory consultancy, export support and regulatory documentation services for pharmaceutical, herbal, nutraceutical and cosmetic products across international markets.
If you want, I can also help you build a complete Middle East regulatory services section with pages for:
Saudi Arabia
UAE
Qatar
Oman
Kuwait
Bahrain
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