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Pharma Regulatory Services in Switzerland - Overview
Switzerland has a well-established and rigorous regulatory framework for medicinal products, overseen by Swissmedic, the Swiss Agency for Therapeutic Products. Whether you're bringing new drugs, generics, biologics, or advanced therapy medicinal products (ATMPs) to the Swiss market, you must comply with strict requirements for quality, safety, efficacy, and labelling.
Freyr offers deep expertise in helping pharmaceutical companies navigate all aspects of these requirements to achieve market authorization and manage product lifecycle in Switzerland.
Pharma Regulatory Services in Switzerland
Freyr Expertise
- Preparation and submission of Marketing Authorisation Applications (MAA) under Swissmedic for:
- Innovative medicinal products (new chemical entities, ATMPs)
- Generics & biosimilars
- Biologics
- Orphan drugs
- Regulatory strategy & gap analysis:
- Early-phase assessment: preclinical / clinical trial planning for Swiss requirements
- CMC (Chemistry, Manufacturing, and Controls) dossier preparation: Swiss specific requirements, import/export, manufacturing site compliance
- Comparative / bridging studies for generics & biosimilars
- Clinical & non-clinical documentation:
- Preparation of clinical study protocols, investigator brochures
- Clinical Trial Authorisation (CTA) submissions to Swissmedic and affiliated ethics committees
- Labelling, safety & pharmacovigilance support:
- Swiss label review & artwork compliance (languages, legal text, Swiss requirements)
- Safety reporting systems conforming to Swissmedic post-market obligations
- Periodic Safety Update Reports (PSURs), Risk Management Plans (RMPs)
- Lifecycle management:
- Variations / amendments (minor / major) post-approval
- Renewals
- Line extensions, switching routes of administration, formulation changes
- Compliance and quality audits:
- Manufacturing site audits (Swiss and international) for GMP / Good Distribution Practice (GDP) readiness
- Regulatory compliance reviews to ensure ongoing alignment with changing Swissmedic guidelines
