🇸🇦 Regulatory Affairs Services – Saudi Arabia
REGULATORY NEXUS GLOBAL
Saudi Arabia 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 Saudi Arabia.
We assist pharmaceutical, nutraceutical, herbal, veterinary and cosmetic companies in navigating the Saudi Arabian regulatory framework and successfully registering their products for the Saudi market.
Our regulatory specialists provide complete regulatory documentation, dossier preparation and submission support aligned with Saudi regulatory authority requirements.
Saudi Arabia Regulatory Authority
Pharmaceuticals, biologicals, medical devices, food supplements and cosmetics in Saudi Arabia are regulated by the Saudi Food and Drug Authority (SFDA).
The authority is responsible for:
• Pharmaceutical product registration and marketing authorization
• Regulation of biological products and vaccines
• Regulation of cosmetics and healthcare products
• Licensing of pharmaceutical importers and distributors
• Pharmacovigilance and post-marketing surveillance
• Ensuring product quality, safety and efficacy
REGULATORY NEXUS GLOBAL provides regulatory documentation and compliance support aligned with SFDA regulatory requirements.
Our Mission
To simplify Saudi Arabia regulatory compliance and enable companies to successfully register and market their products in Saudi Arabia through scientifically sound and compliant regulatory documentation.
Our Core Regulatory Services for Saudi Arabia
Pharmaceutical Product Registration
We prepare Saudi Arabia–compliant pharmaceutical regulatory dossiers for submission to the Saudi Food and Drug Authority.
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 SFDA regulatory guidelines and international regulatory standards.
eCTD / CTD Dossier Preparation
Saudi Arabia requires pharmaceutical registration submissions based on the Common Technical Document (CTD) and electronic CTD (eCTD) format.
Our CTD services include:
• Module 1 – Regional Administrative Information (SFDA-specific)
• 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, GCC regulatory standards and SFDA submission requirements.
Pharmaceutical Registration Process in Saudi Arabia
The general process for pharmaceutical registration includes:
Appointment of a local Saudi authorized agent or Marketing Authorization Holder (MAH).
Submission of the eCTD regulatory dossier via SFDA electronic system.
Technical evaluation of product quality, safety and efficacy.
Regulatory review and GMP verification.
Approval and issuance of Marketing Authorization in Saudi Arabia.
The registration process typically takes 8–14 months depending on product type and regulatory review.
Regulatory Services for Multiple Product Categories in Saudi Arabia
Pharmaceuticals
• Generic drug registration dossiers
• API documentation and DMF support
• Bioequivalence documentation
• CMC documentation
• Stability study documentation
• GMP compliance documentation
Nutraceuticals & Food Supplements
Saudi Arabia has a strong and growing market for nutraceuticals and health supplements.
Our services include:
• Food supplement regulatory documentation
• Ingredient regulatory compliance verification
• Label compliance documentation
• Export regulatory documentation
Herbal & Traditional Products
Herbal and natural healthcare products require regulatory compliance before market entry.
We provide documentation support including:
• Herbal product regulatory dossiers
• Ingredient safety documentation
• Product technical documentation
• Export registration support
Cosmetics & Personal Care Products
Cosmetic products must be registered in the SFDA cosmetic electronic system before marketing in Saudi Arabia.
Our services include:
• Cosmetic Product Safety Report (CPSR) documentation
• Cosmetic Product Information File (PIF) preparation
• Ingredient regulatory compliance verification
• Cosmetic product notification 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 Saudi Arabia
Saudi Arabia Market Entry Support
Our regulatory experts assist companies seeking to enter the Saudi pharmaceutical and healthcare market through:
• Regulatory documentation preparation
• CTD / eCTD dossier development
• SFDA regulatory submission support
• Import/export regulatory documentation
• Market entry regulatory consulting
Why Choose REGULATORY NEXUS GLOBAL
✔ Experienced regulatory affairs professionals
✔ Expertise in SFDA regulatory requirements
✔ ICH and GCC-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 high-value Middle East regulatory pages, such as:
UAE
Qatar
Oman
Kuwait
Bahrain
Jordan