🇮🇱 Regulatory Affairs Services in Israel
REGULATORY NEXUS GLOBAL
Regulatory Affairs Solutions for Pharmaceutical, Nutraceutical, Herbal and Cosmetic Products in Israel
REGULATORY NEXUS GLOBAL is a specialized scientific and regulatory division of Zoesoe Exports Pvt Ltd, providing professional regulatory affairs services for pharmaceutical, nutraceutical, herbal, veterinary and cosmetic companies seeking product registration in Israel.
Israel has a well-developed pharmaceutical regulatory system and follows international regulatory standards similar to ICH, EU, and US regulatory frameworks. Companies planning to export medicines, nutraceuticals, herbal products, or cosmetics to Israel must comply with the country’s regulatory documentation and product approval requirements.
REGULATORY NEXUS GLOBAL supports international manufacturers by preparing Israel-compliant regulatory dossiers, CTD documentation and scientific technical files required for successful product registration.
Regulatory Authority in Israel
Medicinal products and healthcare products in Israel are regulated by the Israeli Ministry of Health, specifically through its Pharmaceutical Administration of Israel.
The regulatory authority evaluates product quality, safety, efficacy, manufacturing compliance and documentation before granting marketing authorization.
REGULATORY NEXUS GLOBAL assists companies in preparing regulatory dossiers aligned with Israeli regulatory guidelines and international standards.
Our Mission
Our mission is to simplify regulatory compliance for the Israeli pharmaceutical and healthcare market and support companies in successfully registering and marketing pharmaceutical, nutraceutical, herbal and cosmetic products in Israel through scientifically sound regulatory documentation.
Core Regulatory Services for Israel
CTD Dossier Preparation
Israel generally follows the Common Technical Document (CTD) format based on ICH guidelines for pharmaceutical product registration.
Our CTD dossier preparation services include:
• Module 1 – Administrative and regional information
• Module 2 – Quality Overall Summary (QOS) and expert reports
• Module 3 – Quality / CMC documentation
• Module 4 – Non-clinical study reports
• Module 5 – Clinical study reports / bioequivalence documentation
All documentation is prepared according to ICH guidelines and Israeli regulatory expectations.
Regulatory Services for Multiple Product Categories
Pharmaceutical Products
• Generic drug registration dossiers
• CTD documentation preparation
• API documentation and Drug Master File (DMF) support
• Bioequivalence documentation
• CMC technical documentation
• Stability study documentation
Nutraceuticals & Food Supplements
Nutraceuticals and dietary supplements in Israel must comply with regulations of the Israeli Ministry of Health.
Our services include:
• Nutraceutical regulatory documentation
• Ingredient regulatory compliance verification
• Product formulation documentation
• Export registration documentation
Herbal & Traditional Medicine Products
Israel recognizes herbal and botanical products under specific regulatory frameworks.
Our services include:
• Herbal medicine regulatory dossiers
• Botanical ingredient documentation
• Traditional medicine regulatory documentation
• Export regulatory documentation
Cosmetics & Cosmeceuticals
Cosmetic products marketed in Israel must comply with cosmetic safety and ingredient regulations enforced by the Israeli Ministry of Health.
Our services include:
• Cosmetic Product Information File (PIF)
• Cosmetic safety documentation
• Ingredient regulatory compliance documentation
• Cosmetic export registration support
Veterinary Products
• Veterinary medicinal product dossiers
• Veterinary regulatory documentation
• Export regulatory compliance support
Additional Regulatory Support
REGULATORY NEXUS GLOBAL also provides:
• Technical document writing
• Product development reports
• Analytical method validation documentation (ICH Guidelines)
• Clinical trial and bioequivalence documentation
• Regulatory gap analysis
• Regulatory strategy planning
• Export registration support for Israel
Why Choose REGULATORY NEXUS GLOBAL
✔ Experienced regulatory affairs professionals
✔ Expertise in CTD dossier preparation
✔ Compliance with international regulatory standards
✔ Regulatory support for pharmaceuticals, nutraceuticals, herbal and cosmetics
✔ Reliable scientific documentation
✔ End-to-end regulatory solutions for Israel market entry
About Zoesoe Exports Pvt Ltd
REGULATORY NEXUS GLOBAL operates as the scientific regulatory arm of Zoesoe Exports Pvt Ltd, a company engaged in global export consultancy, regulatory affairs services and contract manufacturing coordination for pharmaceutical, herbal, nutraceutical and cosmetic products.
Through its regulatory division, the company provides professional regulatory documentation and international product registration support for Israel and other regulated global markets.