Regulatory Affairs Service in Lebanon

Lebanon maintains a defined regulatory system for pharmaceutical products to help ensure that medicines supplied to patients meet applicable standards for quality, safety and efficacy. Pharmaceutical products, whether manufactured locally or imported, are required to be registered with the Lebanese Ministry of Public Health (MoPH) before they can be legally distributed in the country.

For pharmaceutical and biotechnology companies planning to enter the Lebanese market, regulatory preparation involves more than assembling documents for submission. Companies need to understand the applicable product pathway, assess whether existing global documentation meets local expectations, prepare the technical dossier correctly and manage regulatory requirements throughout the product lifecycle.

DDReg provides Regulatory Services in Lebanon for pharmaceutical and life sciences companies that require structured regulatory strategy, dossier preparation, gap assessment, CMC support, submission management and post-approval lifecycle assistance.

Companies evaluating Pharmaceutical Regulatory Services Lebanon can therefore benefit from beginning regulatory planning before the intended submission date rather than treating registration as a final administrative activity.

The regulatory pathway for a pharmaceutical product in Lebanon depends on the product category, its regulatory history, available approvals and the technical documentation supporting the application.

The Ministry of Public Health (MoPH) publishes pharmaceutical registration requirements and specific guidance for certain product categories, including biosimilars. The appropriate pathway should therefore be assessed before dossier preparation begins.

Assessing these factors early helps identify the appropriate regulatory approach and potential dossier gaps before submission.

Once the applicable pathway and documentation requirements have been established, the product can progress through the pharmaceutical registration process.

1. Product & Dossier Assessment

Review the product profile, regulatory status, manufacturing arrangements, existing approvals and available technical documentation.

2. Gap Analysis & Documentation Preparation

Compare the available dossier with applicable MoPH requirements and address missing, outdated or inconsistent administrative and technical information.

3. Technical File Finalization

Prepare and organize the required technical documentation. For applicable pharmaceutical submissions, MoPH guidance covers Module 3 Part S for drug substances, Module 3 Part P for finished products and Module 5 for bioequivalence.

4. MoPH Submission

Submit the completed administrative and technical documentation through the applicable MoPH pharmaceutical registration process.

5. Regulatory Review & Query Management

The application is reviewed within the MoPH framework under the control of the Drug Registration Technical Committee. Additional clarification or supporting documentation may be requested during assessment.

6. Regulatory Decision & Post-Approval Management

Following completion of the applicable regulatory assessment, a decision on registration is reached. After authorization, changes affecting approved product information, manufacturing, quality documentation or labeling should be assessed for any applicable post-approval regulatory requirements.

DDReg supports pharmaceutical and life sciences companies across the regulatory lifecycle by combining regulatory strategy , dossier expertise, CMC support, medical writing, submission management and post-approval assistance.

• + Regulatory Strategy and Pathway Assessment
  • Assess the product profile, development history and available regulatory documentation.
  • Identify the most appropriate regulatory approach for the Lebanese market.
  • Review potential documentation requirements before dossier preparation begins.
  • Highlight possible regulatory risks and gaps early in the process.
• + Dossier Gap Analysis and Remediation
  • Review existing dossiers against applicable regulatory requirements.
  • Identify missing, incomplete or inconsistent technical documentation.
  • Assess administrative, quality, clinical and nonclinical documentation.
  • Develop remediation plans to address significant dossier deficiencies.
  • Improve dossier submission readiness before filing.
• + CTD Dossier Preparation and Review
  • Support preparation and organization of CTD-based regulatory documentation.
  • Review dossier content for scientific and regulatory consistency.
  • Help adapt existing global dossiers for applicable market requirements.
  • Check consistency across quality, clinical, nonclinical and administrative sections.
  • Perform submission-readiness reviews before finalization.
• + CMC Regulatory Support
  • Support preparation and review of Chemistry, Manufacturing and Controls documentation.
  • Review drug substance and finished product information.
  • Support documentation covering manufacturing processes and controls.
  • Review specifications, analytical methods and supporting quality information.
  • Assist with CMC documentation required during product lifecycle changes.
• + Regulatory Submission and Publishing Support
  • Organize regulatory documentation into submission-ready formats.
  • Support dossier compilation and document management.
  • Maintain consistency across submitted regulatory documents.
  • Assist with submission planning and publishing activities.
  • Support preparation of documentation required during regulatory review.
• + Regulatory and Scientific Writing
  • Prepare and review regulatory and scientific documents.
  • Support CTD summaries and technical documentation.
  • Develop clear responses to regulatory questions and deficiencies.
  • Support clinical, nonclinical and safety-related regulatory writing services.
  • Improve scientific clarity and consistency across submission documents.
• + Labeling Support
  • Review pharmaceutical product labeling and product information.
  • Support development and revision of labeling documentation.
  • Assess labeling changes during post-approval activities.
  • Maintain consistency between product information and regulatory documentation.
  • Support regulatory documentation associated with labeling updates.
• + Regulatory Intelligence
  • Monitor relevant regulatory requirements and guidance.
  • Assess regulatory changes that may affect planned or approved products.
  • Support country-specific regulatory research.
  • Provide regulatory pathway and market-entry intelligence.
  • Evaluate the possible impact of changing requirements on regulatory strategy.
• + Post-Approval Lifecycle Management
  • Assess regulatory impact of post-approval product changes.
  • Support variation strategy and documentation.
  • Assist with renewal-related regulatory documentation.
  • Support CMC and labeling changes throughout the product lifecycle.
  • Help maintain regulatory consistency for approved products.
• + Health Authority Query Support
  • Review questions or deficiencies raised during regulatory assessment.
  • Coordinate scientific and technical inputs required for responses.
  • Prepare structured and evidence-based response documentation.
  • Maintain alignment between original dossier content and subsequent responses.
  • Support response-document readiness before submission.

Through these services, DDReg helps companies manage regulatory activities in a structured manner, from initial dossier assessment and submission preparation to post-approval lifecycle management.

DDReg supports pharmaceutical, biotechnology, medical-device and healthcare companies seeking compliant market access in Lebanon.

Our Regulatory Affairs Consultant Lebanon support combines global regulatory expertise with an understanding of Lebanese Ministry of Public Health (MoPH) requirements, helping companies assess the appropriate regulatory pathway, prepare accurate documentation and manage regulatory activities throughout the product lifecycle.

Our Capabilities Include:

• 17+ years of global regulatory expertise
• Regulatory pathway and market-entry assessment
• Dossier gap analysis and submission preparation
• CTD dossier review and documentation support
• CMC regulatory support
• End-to-end lifecycle management
• Multi-country regulatory support
• Pharmaceutical, medical-device, IVD and cosmetic regulatory expertise
• Dedicated regulatory specialist teams
• Regulatory intelligence and change monitoring
• Post-approval regulatory support