🇨🇭Regulatory Affairs Services in Switzerland
REGULATORY NEXUS GLOBAL
Regulatory Affairs Solutions for Pharmaceutical, Nutraceutical, Herbal and Cosmetic Products in Switzerland
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 Switzerland.
Switzerland is one of the world’s leading pharmaceutical markets and home to several global pharmaceutical companies. Although Switzerland is not a member of the European Union, its regulatory framework follows international standards similar to EU and ICH guidelines.
REGULATORY NEXUS GLOBAL supports international manufacturers by preparing Swiss-compliant regulatory dossiers, CTD documentation and scientific technical files required for successful product registration in Switzerland.
Regulatory Authority in Switzerland
Medicinal products and healthcare products in Switzerland are regulated by Swissmedic, the Swiss Agency for Therapeutic Products.
Swissmedic is responsible for evaluating product quality, safety, efficacy, manufacturing compliance and regulatory documentation before granting marketing authorization.
REGULATORY NEXUS GLOBAL assists companies in preparing regulatory dossiers aligned with Swissmedic guidelines and international regulatory standards.
Our Mission
Our mission is to simplify regulatory compliance for the Swiss pharmaceutical and healthcare market and support companies in successfully registering and marketing pharmaceutical, nutraceutical, herbal and cosmetic products in Switzerland through scientifically sound regulatory documentation.
Core Regulatory Services for Switzerland
CTD Dossier Preparation
Pharmaceutical product registration in Switzerland generally follows the Common Technical Document (CTD) format based on ICH guidelines.
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 Swissmedic regulatory expectations.
Regulatory Services for Multiple Product Categories
Pharmaceutical Products
• Generic drug registration dossiers
• CTD dossier preparation
• API documentation and Drug Master File (DMF) support
• Bioequivalence documentation
• CMC technical documentation
• Stability study documentation
Nutraceuticals & Food Supplements
Food supplements in Switzerland must comply with regulations overseen by the Federal Food Safety and Veterinary Office (FSVO).
Our services include:
• Nutraceutical regulatory documentation
• Ingredient regulatory compliance verification
• Product formulation documentation
• Export regulatory documentation
Herbal & Traditional Medicine Products
Switzerland has strong regulatory standards for herbal medicines and traditional medicinal products.
Our services include:
• Herbal medicine regulatory dossiers
• Botanical ingredient documentation
• Traditional medicine regulatory documentation
• Export regulatory support
Cosmetics & Cosmeceuticals
Cosmetics marketed in Switzerland must comply with cosmetic safety regulations aligned with European cosmetic legislation.
Our services include:
• Cosmetic Product Information File (PIF)
• Cosmetic safety documentation
• Cosmetic regulatory compliance documentation
• Ingredient regulatory compliance
Veterinary Products
Veterinary medicinal products are regulated by the Swissmedic and other veterinary authorities.
Our services include:
• 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 Switzerland
European Market Support
REGULATORY NEXUS GLOBAL supports regulatory documentation and product registration across Europe including:
• Switzerland
• Germany
• France
• Netherlands
• Belgium
• Austria
• Denmark
• Sweden
• Finland
• Ireland
Why Choose REGULATORY NEXUS GLOBAL
✔ Experienced regulatory affairs professionals
✔ Expertise in CTD dossier preparation
✔ Compliance with Swissmedic regulatory requirements
✔ Regulatory support for pharmaceuticals, nutraceuticals, herbal and cosmetics
✔ Reliable scientific documentation
✔ End-to-end regulatory solutions for Switzerland 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 Switzerland and other regulated global markets.