🇯🇴 Regulatory Affairs Services – Jordan
REGULATORY NEXUS GLOBAL
Jordan 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 Jordan.
We assist pharmaceutical, nutraceutical, herbal, veterinary and cosmetic companies in navigating the Jordanian regulatory framework and successfully registering their products for the Jordan market.
Our regulatory specialists provide complete regulatory documentation, dossier preparation and submission support aligned with Jordan regulatory authority requirements.
Jordan Regulatory Authority
Medicines, vaccines, medical products and cosmetics in Jordan are regulated by the Jordan Food and Drug Administration (JFDA).
The authority operates under the Government of Jordan and is responsible for:
• Pharmaceutical product registration and approval
• Regulation of medicines, vaccines and biological products
• Import and export licensing for medical products
• Regulation of cosmetics and health supplements
• Post-marketing surveillance and pharmacovigilance
REGULATORY NEXUS GLOBAL provides regulatory documentation and compliance support aligned with JFDA regulatory requirements.
Our Mission
To simplify Jordan regulatory compliance and enable companies to successfully register and market their products in Jordan through scientifically sound and compliant regulatory documentation.
Our Core Regulatory Services for Jordan
Pharmaceutical Product Registration Dossiers
We prepare Jordan-compliant pharmaceutical regulatory dossiers for submission to the Jordan Food and Drug Administration.
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 JFDA regulatory guidelines and international regulatory standards.
CTD Dossier Preparation
Jordan accepts regulatory submissions based on the **Common Technical Document (CTD) format.
Our CTD services include preparation of:
• Module 1 – Regional 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 team ensures dossiers comply with ICH guidelines, WHO standards and JFDA regulatory expectations.
Pharmaceutical Registration Process in Jordan
The general process for pharmaceutical product registration in Jordan includes:
Appointment of a local Jordanian agent or distributor.
Submission of CTD regulatory dossier and legal documentation to JFDA.
Technical evaluation of quality, safety and efficacy.
Laboratory testing and regulatory review.
Approval and issuance of Marketing Authorization in Jordan.
The registration process typically takes 6–12 months depending on product category and regulatory review.
Regulatory Services for Multiple Product Categories in Jordan
Pharmaceuticals
• Generic drug registration dossiers
• API documentation and DMF support
• Bioequivalence documentation
• CMC documentation
• Stability study documentation
• GMP compliance documentation
Nutraceuticals & Health Supplements
Jordan has a growing market for nutraceutical and health supplement products.
Our services include:
• Product technical documentation
• Ingredient regulatory compliance verification
• Label compliance documentation
• Export regulatory documentation
Herbal & Traditional Medicine Products
Herbal medicines are widely used in Jordan.
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 Jordan must comply with JFDA safety and regulatory 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 Jordan
Jordan Market Entry Support
Our regulatory experts assist companies seeking to enter the Jordan pharmaceutical and healthcare market through:
• Regulatory documentation preparation
• CTD-compliant dossier development
• JFDA regulatory submission support
• Import/export regulatory documentation
• Market entry regulatory consulting
Why Choose REGULATORY NEXUS GLOBAL
✔ Experienced regulatory affairs professionals
✔ Expertise in Jordan JFDA 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 create complete Middle East regulatory country pages for:
Saudi Arabia
UAE
Oman
Qatar
Kuwait
Bahrain
Lebanon