We have been working with SFL for a year and the experience could not have been more positive. SFL has advised us and helped us to create a global Pharmacovigilance system (HQ) with two affiliates in Europe (Italy and France). SFL has provided us with a personalized service, high-quality work and a rigorous deadline compliance. Currently, SFL, through the coordination between the HQ and the affiliates, keeps harmonized the whole Pharmacovigilance system, by providing all its experience, point of view and teamwork. I am very grateful for its incredible support
EU-QPPV Laboratorios Alter S.A. Spain.
SFL has provided great regulatory support over the years to our team. We have benefitted from in-house support with dedicated and reliable colleagues from SFL.
SFL showed commitment and provided focussed service on our projects, including clinical trial regulatory management, post-approval regulatory activities and continuing contribution to general regulatory intelligence topics. We also appreciate their expertise in rare diseases. We highly recommend SFL’s services.
Head Drug Regulatory Affairs, Santhera Pharmaceuticals
SFL provided support by acting as interim Head of the Regulatory Affairs Department to allow a smooth internal transition while ensuring all RA activities could be continued, and the knowledge remained available in house. SFL expertise, dedication and availability, as well as representation of Mathys in interactions with our Notified Body, was greatly appreciated within our team.
Additionally, SFL supported a gap analysis of our technical documentation in prevision of the upcoming MDR implementation and assisted us on the necessary upgrade of our Quality Management System for compliance with these new requirements.
CEO, Mathys Ltd.
The support you provided us at PerioC Ltd was excellent! I have to say that the scientific advice meeting at the Swedish Health Authority that you prepared and ran for us was one of the best I have experienced in all my years in Regulatory Affairs in Big Pharma! Thanks again for the excellent support!
CEO, PerioC Ltd.
As Quality Director for EEA, CH and UK in a biotech company active in the gene therapy, I have the privilege to be accompanied by a team of highly professional experts from the SFL team. SFL always demonstrates a deep and up-to-date knowledge of the regulations and trends together with a business pragmatic approach that helps to always find simple and compliant solutions. The three SFL people I am working with are very responsive in any circumstances and they are always available to bring appropriate responses and support in a timely manner. Despite the contractual relationship between a customer and a vendor, very quickly we considered the SFL experts as members of our team since their engagement is so reliable and the team spirit so good. It is a real pleasure to work with such professional people and I can only recommend SFL with no reserve.
Quality Director, Biotech company active in gene therapy
SFL provided an outstanding level of support for our Swiss MAA for an innovative oncology product, reviewed under the auspices of Project ORBIS. SFL acquainted themselves with the project rapidly and efficiently, meeting all of our needs for an expedited, pragmatic and highly successfully submission and review procedure. Their expert advice and unfailing support were invaluable in obtaining a rapid approval for our product. Furthermore, SFL has been helping our company with a number of activities needed for the EU MAA application, again with an abundance of grace, flexibility and credibility. I’m very grateful to SFL for their amazing support.
Head of EU/RoW Regulatory Affairs, US Pharma Company with growing European presence
SFL provided us with high quality strategic guidance and full operational support, on both regulatory affairs and medical writing. This has enabled us to quickly gain Orphan Designation and to submit for Marketing Authorization Application in Switzerland, without being established in the country.
SFL is a trusted partner, and we feel their “right first time” approach is fully tailored to our needs as an SME.
Global Head Regulatory Affairs & Compliance, France HQ SME
Recent changes in the regulation of medical devices, have put intermediate size companies like ours under huge pressure. SFL efficiently helped us in setting up the right strategy and provided excellent assistance in the preparation of clinical evaluation in agreement with the defined planning.
Head of Clinical Affairs, French Medtech Company
“What distinguishes SFL is competence, a wide knowledge base and many years’ experience, combined with a well structured approach which is open, customer-oriented, honest and very constructive.”
“As both the one-day in-house training course and the supporting documentation strengthened our understanding and our ability to target our activities, we consider the tailored SFL training an effective use of our resources.”
Head Medical Device, F. Hoffmann-La Roche Ltd
The SFL team has been an excellent partner for us. Our very small, privately held, US based company needed help navigating the EU PIP process. The SFL regulatory and medical writing team were easy to work with, efficient, and delivered on time with high quality. Our product and development program were quite unique and the SFL team came up to speed quickly and offered good strategic input. They made our first entry into the EU regulatory space a smooth one and felt as though they were an extension of our internal team. We highly recommend their services!
VP Regulatory Affairs & Clinical Operations, Elusys Therapeutics, Inc.
“We have worked with SFL for almost two years and are highly satisfied with the work they have done for us. IPM develops safe and effective HIV prevention tools for use by women in developing countries. To support our goal of establishing a legal non-profit entity in the European Union (EU), we needed expert legal advice. We chose to work with SFL because not only have they outperformed their competitors with thorough and thoughtful legal advice, their professionalism and personal attention makes working with them a pleasure. SFL has provided IPM with legal support in several areas, including analysis of data protection law, review of contracts, and helped us set up a Brussels office in support of our new legal entity in Belgium. They gave us clear guidance and were well versed in EU law and their materials prepared in support of our activities were applauded by our Board of Directors. SFL’s team gives us wonderful support and we are grateful for their proactive and timely contributions. In this regard, speaking for the entire team at IPM, we enthusiastically recommend SFL to anyone in need of legal support.”
“The team at IPM has worked with SFL for almost two years and we are delighted with the work they have done for us. IPM develops safe and effective HIV prevention tools for use by women in developing countries and SFL was highly recommended to us from one of our Board members. SFL certainly has lived up to all expectations — to the fullest extent. Starting with a thorough pharmacovigilance (PV) gap analysis of the existing infrastructure, they have now provided outstanding expertise to expand the system to a state-of-the-art PV model supporting the Dapivirine Vaginal Ring approval process. In addition to being professional, well organized, and subject matter experts, they were pleasant and easy to work with. SFL was extremely responsive to our needs and quickly delivered high-quality deliverables well within our deadlines. We would highly recommend working with them.”
President and COO, International Partnership For Microbicides
“I’ve been working together with SFL since many years. I have had only the most positive experiences with SFL team. Every assignment has been handled extremely well and SFL’s exceptionally collaborative teamwork should be mentioned. It has been great working with a team of professionals who really know their business!”
Head of Regulatory Affairs, Finox Biotech
“We experienced SFL as strongly customer-oriented, flexible, committed to deadlines, scientifically sound and a very pleasant cooperation partner.”
Global Head Regulatory Affairs, Grünenthal GmbH
“The in-depth training for our development and clinical teams provided by SFL helped the trained departments to grasp in more detail the complexities of the regulations and forthcoming developments and judge how best to create improved internal mechanisms to successfully and efficiently meet the requirements.”
Head Regulatory Affairs, Nobel Biocare
“Excellent support in the conduct of a new and very interactive satellite symposium concept. The quality of the scientific content was outstanding and highly appreciated by the speakers and exceeded our expectations based on the experience with other agencies in the past.”
Head Medical Affairs, Vifor Pharma Ltd.
“SFL is an extremely professional company with comprehensive know how in writing clinical evaluation reports for medical devices.”
Head Clinical Affairs, Straumann
SFL has provided excellent strategic regulatory advice on combination, borderline and medical device products. In addition, they recently provided an in-house training day on current and future medical devices legislation at Boehringer Ingelheim; helping us define our strategy to prepare for upcoming changes in the European regulatory landscape.
Global Head RA Consumer Health, Boehringer-Ingelheim
SFL team has provided very personalized and high quality service for EU, Switzerland, Argentina and Turkey always according to agreed timelines. We can highly recommend SFL.
Head of Global Regulatory Affairs, Basilea Pharmaceutica
SFL is providing excellent support in terms of regulatory intelligence for medical devices and also from a policy angle. A truly global team with many insights to share.
Head Europe Global Regulatory & Scientific Policy, Merck-Serono
SFL supports us in our public affairs activities in the EU. We appreciate both the depth and breadth of their understanding of the legislative framework and political landscape, as well as their knowledge of the lifecycle of our medicinal products and medical devices. This unique combination of expertise makes SFL a trusted partner for our public affairs activities in the complex environment of the healthcare industry. Whether SFL assesses the impact of legislative developments on our business or supports us with the development of communication material, we can rely on scientifically robust outcomes that meet our high expectations.
Head of Group Government Affairs, F. Hoffmann-La Roche Ltd.
SFL has provided Vifor with comprehensive regulatory strategy, regulatory intelligence, medical communication and legal support. SFL has been effective preparing and implementing global regulatory submissions under a very tight timelines.
Head Global Regulatory Affairs, Vifor Pharma Ltd.