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SFL Regulatory Affairs & Scientific Communication Ltd.
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Gateway to regulatory success and market entry in Switzerland

Our expertise facilitates successful and speedy registration and market access for medicinal products in Switzerland.

SFL has a full quality management system and holds a Swissmedic establishment license, a pre-requisite for submitting marketing authorization applications (MAA) in Switzerland. Therefore, on behalf of our clients, who do not have a Swiss subsidiary or do not have the necessary Swissmedic licenses, we act as applicant of MAA in Switzerland and bring your innovative products onto the Swiss market in compliance with Swiss law.

RegulatoryMarket accessPost-market support
Regulatory strategy, ODD, CTAMarket access strategy for medicinal productsFull lifecycle management including RA, PV and QA support
Establishing quality management systemsSupport with early access schemesRegulatory submissions
Acting as applicant and MAHWriting and submission of Swiss value dossiersActing as Swiss Quality, PV and Compliance Responsible Persons
MAA filing and liaison with SwissmedicLiaison with HTA and reimbursement bodiesAuditing distributors on clients’ behalf

  • Services

  • Regulatory Affairs
  • Quality Assurance & GxP Compliance
  • Medical Affairs & Communication
  • Market Access & Reimbursement
  • Public Affairs & Regulatory Intelligence
  • Medical Devices, Combination Products and IVDs
  • Pharmacovigilance & Clinical Safety
  • Supply Chains of Medicines and Devices
  • Legal & Healthcare Compliance
  • Swiss Support
  • UK Support
  • Clinical Trials support

Switzerland – Main Office

SFL Regulatory Affairs & Scientific Communication GmbH
Aeschenvorstadt 52 | CH-4051 Basel
Email: office@sfl-services.com
Phone: +41 61 361 9443

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