SFL Regulatory Affairs & Scientific Communication GmbH

SFL Regulatory Affairs & Scientific Communication Ltd (SFL) is a multi-national team with extensive experience in the pharmaceutical as well as medtech industries.

SFL’s core competencies are:
• Regulatory Affairs and Quality Assurance
• Medical Affairs and Pharmacovigilance
• Public Affairs
• Commercial and Market Access
• Legal Advice and Compliance



This enables us to understand and meet clients’ needs through every stage of the product lifecycle. Each team member has a proven track record in specific areas of expertise and an excellent understanding of the interconnectedness of the different stages and functions of the lifecycle of a product.

Public Affairs Services
SFL advises organizations on how to engage in the EU debate to shape healthcare policies and regulatory frameworks. Our team has extensive hands-on experience and proven success in contributing to EU healthcare laws and policies. SFL's public affairs team has worked in functions inside the industry as well as in the public sector. Our public affairs services comprise:
EU policy intelligence (monitoring, impact analysis of coming/changing laws and policies, news updates tailored to client needs)
Engagement strategy (stakeholder mapping, strategic partnerships, working with industry associations, step-by-step plans to address policy and regulatory matters, support with drafting communication materials, coordination of workshops and debates)
Capacity building (training on EU institutions and legislative processes, public affairs methods and tools, lobbying codes, advice on internal organizational matters to help clients formulate aligned positions and speak with one voice to regulators and policy-makers)

SFL supports its clients by offering personalized and comprehensive services which, when combined, provide an integrated solution for products from the bench to the marketplace within one consultancy.
SFL offers expertise in the following product classes - drugs, medical devices, in vitro diagnostics, combination products, and advanced therapy medicinal products (ATMPs) - and in a broad range of therapeutic areas.

SFL is co-founder of the associations Medtech & Pharma Platform (MPP) and Rare Disease Action Forum (RDAF).

Proposal for a Regulation on Health Technology Assessment - 2018/018 (COD)
Medical Devices Regulation - EU No 2017/745
In-vitro Diagnostics Regulation - EU No 2017/746
Clinical Trials Regulation - EU No 536/2014
Data Protection Regulation - EU No 2016/679
EUnetHTA
Proposal for a Regulation on the supplementary protection certificate for medicinal products - 2018/0161/COD
European Medicines Agency policy on publication of
clinical data for medicinal products for human use - EMA/240810/2013
Blood, tissues & cells Directives (2002/98/EC and 2004/23/EC, respectively)
The Cybersecurity Act 2017/0225(COD)
Horizon Europe
EU pharmacovigilance system including Regulation No 1235/2010 and Directive 2010/84/EU as integrated in Regulation (EC) No 726/2004 and Directive 2001/83/EC
EU personalised medicine activities such as Use of '-omics' technologies in the development of personalised medicine SWD(2013) 436 final
Orphan Drug Regulation - EU No 141/2000

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1.5

No lobbyists with EP accreditations

None declared

Ms Shayesteh Fürst-Ladani (CEO)

Ms Shayesteh Fürst-Ladani (CEO)

I - Professional consultancies/law firms/self-employed consultants

Professional consultancies