Swissmedic Establishment License
We offer full strategic and operational support to facilitate the successful introduction of medicinal products, including Pharmaceuticals, Medical Devices, Software as Medical Devices, IVDs, and Companion Diagnostics products, into the Swiss market.
We handle all aspects of the regulatory process, from establishing a local affiliate to building and maintaining Swiss Quality Management Systems (QMS) and overseeing post-approval licensing and maintenance (LCM).
We support you in securing your Pharmaceutical Establishment License (PEL) and ensure strict compliance with Swissmedic regulations.
Helix Life Sciences provides Responsible Person (FvP/QP) and deputy services in full compliance with Swiss law, as well as acting as the local Responsible Person for pharmacovigilance (QPPV). We also ensure seamless regulatory compliance by preparing, attending, and following up on Swissmedic inspections on behalf of our clients.
- Our Capabilities
Accelerate Your Business Development Plans
Regulatory Expertise
Helix Life Science provides expert representation and guidance to foreign companies navigating Swiss regulatory requirements, ensuring seamless compliance and market access.
Streamlined Submissions
Helix Life Science serves as the authorized applicant for Swiss Marketing Authorization Applications (MAAs), taking full responsibility for handling the entire regulatory submission process, from start to finish, for medical product manufacturers.
Trusted Liaison
Helix Life Science acts as a liaison between foreign companies and Swiss regulatory authorities, including SWISSMEDIC and FOPH/BAG, facilitating communication and ensuring seamless collaboration throughout the Swiss market access process.
- Market Presence
Tailored plans to establish your pharmaceutical business in Switzerland
Seamlessly enter the Swiss market with our expert support, ensuring regulatory compliance and product conformity.
Navigate complex Swiss regulations efficiently, as our team handles all aspects from local affiliate establishment, MAA submissions to ad hoc Swissmedic authorizations.
Establish a reputable brand in Switzerland, gaining recognition and trust among healthcare professionals and consumers.
Regulatory Experts
We provide expert representation on behalf of foreign companies before Swiss regional and cantonal authorities, ensuring seamless compliance with local regulations. We also act as liaison between foreign companies and Swiss federal authorities, primarily Swissmedic (Swiss Medicines Agency) and FOPH/BAG (Swiss Health Technology Assessment body). Furthermore, we serve as the authorized applicant for Swiss Marketing Authorization Applications (MAAs), handling the entire regulatory submission process from start to finish.
Our team of experienced regulatory experts possesses a deep understanding of Swiss regulatory requirements and a proven track record of success in guiding medical product manufacturers through the complex Swiss market access process. We are committed to providing our clients with personalized and tailored support to ensure the timely and successful introduction of their products into the Swiss market.
Our process
Getting to Know You
Prior to formal engagement, we prioritize understanding your personal situation, financial goals, and key concerns that drive your search for financial advice. This forms the basis for a mutually agreed-upon scope of work. Please find below a comprehensive list of our capabilities.
Gaining Clarity on Your Finances
Our comprehensive planning engagements start by jointly assessing your balance sheet and cash flow. Access our secure client portal to upload documents or link your accounts electronically.
Building Your Financial Vision
We collaborate with you to prioritize your goals and assess the financial choices and risks involved in achieving them. Through close partnership, we establish a baseline projection of your future financial wealth, providing a roadmap for your success.
Analyzing Tradeoffs
We use our financial model to develop alternative scenarios, informing recommendations on taxes, insurance, and investments to align with your goals. Exploring scenarios to align recommendations.
Start Your Journey with Helix
Drop your contact details into the form, and we’ll reach out to you!
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Start
Your
Journey
With Helix.
Drop your contact details into the form, and we’ll reach out to you!
