Our Comprehensive Solution
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.
- Our Capabilities
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 OFSP/BAG, facilitating communication and ensuring seamless collaboration throughout the Swiss market access process.
- Our Capabilities
Tailoring plans using listed capabilities
Investment Planning
We analyze your current investment approach and engage in insightful discussions to provide recommendations for your next steps. For clients seeking ongoing investment services, we encourage you to explore our comprehensive Wealth Management service. By leveraging our expertise, we aim to optimize your investment strategy and assist you in achieving your financial objectives.
Retirement Planning
Whether retirement is a distant goal or just around the corner, we are here to assist you in reviewing your current retirement plan and making necessary decisions to ensure its success. At every step of the way, our goal is to provide you with the information and support needed to make confident and well-informed choices.
Education Planning
We understand the importance of balancing education planning with your overall financial goals, and we're here to assist you every step of the way. By working together, we can ensure that education planning becomes an integral part of your comprehensive financial plan, helping you make informed decisions, educational future while maintaining your overall financial well-being.
- Client Goals
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 to MAA submissions.
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 OFSP/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
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Start
Your
Journey
With Helix.
Drop your contact details into the form, and we’ll reach out to you!
