Marketing Authorization andRegulatory Services
Successfully bringing your medicinal products to the market in Switzerland requires expert navigation of the Swiss regulatory system. We offer strategic guidance and comprehensive support throughout the Marketing Authorization process, facilitating efficient and compliant market entry.
We support innovators as well as generic product sponsors, leveraging our Swiss regulatory expertise to transition seamlessly from clinical trials to market authorization. Our commitment is to accelerate patient access to new and cost-effective treatments, ensuring optimal regulatory outcomes tailored to your product type.
Our services include
Strategic Regulatory Consulting
Tailored regulatory strategies aligned with your product profile, whether innovative (new active substance, NAS) or generic (known active substance, KAS), optimizing your submission pathway.
Preparation of Submission Dossiers
Meticulous preparation and management of Marketing Authorization Applications (MAA) in strict compliance with Swissmedic requirements.
Regulatory Liaison and Follow-up
Proactive communication with Swissmedic throughout the authorization process, ensuring efficient progress toward approval.
Post-Approval Support
Ongoing assistance including lifecycle management, variations, renewals, extension of indication and compliance monitoring.
Access Consortium: Simultaneous Authorization in Multiple Markets
In addition, GALSER can facilitate your participation in the Access Consortium program. This collaborative initiative allows simultaneous submission and joint review by regulatory authorities from five leading markets: Switzerland, Canada, Australia, Singapore, and the United Kingdom.
Through this pathway, your dossier undergoes a coordinated evaluation, resulting in simultaneous regulatory approvals across these key markets. This approach significantly enhances efficiency, accelerates international market entry, and maximizes your global regulatory strategy.
Orphan Drug Designation:
GALSER also supports sponsors in securing Orphan Drug Designation (ODD) in Switzerland. This regulatory status is granted to medicinal products intended for the diagnosis, prevention, or treatment of rare diseases, providing significant development and market access incentives. Our services include strategic advice on eligibility assessment, preparation and submission of the ODD application to Swissmedic, and regulatory liaison throughout the review process. Obtaining ODD can offer benefits such as reduced fees, regulatory support, and potential market exclusivity, strengthening your product’s development and commercialization strategy.
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