We combine regulatory expertise with commercial understanding and scientific experience. After all, it is all about managing risks and expectations. Making sure that your time and money is spent in the best way. Spearheading your work to the next phase. Always with eyes both on the bigger picture and the details. Because both are essential for the end result.
Welcome to Regsmart
We support you with regulatory experience based on firm scientific knowledge and commercial understanding. Progress in research and development comes from teamwork, and we are committed to bring the regulatory aspects to the table. By including the regulatory aspects early on in your project, the path to market access can be influenced and time to market minimized.
All projects are different and there are rarely any standard solutions to the challenges in product development. Even though regulatory guidelines are for everyone to read, our job is to read between the lines and put the current regulatory thinking in the context of the scientific opportunities in the individual project.
We will help you look into the future and predict in what direction regulations are heading. Welcome for a first contact!
Our services
We provide scientifically based strategic and operational support and strong advice to companies and academia from early research throughout the product lifecycle. We provide regulatory and scientific expertise in all areas of drug development.
As experts in Medical Device Regulation, we support you in developing a clinical development strategy for your medical device, as well as help you develop a cost-efficient regulatory plan and build and implement the required quality management system.
We have long experience in In-Vito Diagnostic Regulation, and know the requirements when it comes to generating the required clinical evidence. We help you with your IVD device, from clinical development strategy to regulatory plans and implementation.
What we do
Our fundamental understanding of the regulatory requirements and current thinking helps us to develop the best regulatory strategy for your product.
We help you design development studies that are consistent with their intended scientific purpose and will gain relevant knowledge for science-based regulatory submissions.
By combining the understanding of regulatory demands and market dynamics with scientific knowledge we identify the critical steps to be performed and how to present the obtained results in a manner suitable for regulatory and business evaluation.
Pharmacovigilance
Read moreHOW WE HELP OUR CUSTOMERS
Proudly presenting the RegSmart pharmacovigilance team!
Katarina Andersson and Sari Öbrink bring 30+ years of experience from the area of post marketing pharmacovigilance from both the Swedish Medical Products Agency and the pharmaceutical industry. They provide valuable insight in achieving efficient and well-functioning, fit for purpose pharmacovigilance systems in compliance with the regulations.
Most welcome for a first contact to discuss your needs in the pharmacovigilance area!
“RegSmart has been very helpful for us in understanding the regulatory requirements for our innovative solution”
CEO and Senior Advisor
M Sci Pharm, Ph D
marie.gardmark@regsmart.se +46 (0)765 – 27 62 65
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Senior Advisor
M Sci Pharm, Ph D
agneta.larhed@regsmart.se +46 (0)727- 46 73 50
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Director Medical Device & IVDR, Senior Consultant
MSc, MBA
mats.hogberg@regsmart.se +46 (0) 705 – 46 50 21
Läs merRegSmart Life Science is a regulatory consultancy firm in pharma and medical device that will help you navigate in a complex and evolving regulatory landscape. With our long regulatory experience from senior positions at a regulatory agency and from small and big life science companies we facilitate your work by knowing ”what to do, when and how”. We provide fit for purpose advice and support in relation to European and US regulatory requirements, helping you to develop a regulatory plan as part of your overall project strategy. Our expertise is to analyse and interpret the guidance provided and decisions taken by regulatory agencies in EU and US and help answer the specific questions in your projects. We provide support from early research throughout your product life-cycle, always with the target product profile in mind.
24.06.24
Are you Pharmacovigilance inspection-ready?
If not – we are here for you. We have long experience from the pharmaceutical industry, government inspections and expertise in pharmacovigilance legislation. We perform audits of marketing authorisation holder (MAH), partner companies and service providers to identify GAPS in the pharmacovigilance system.
24.05.22
Welcome to RegSmart, Sari Öbrink
This spring, you joined the RegSmart team as senior advisor pharmacovigilance. Tell us, what is your background prior to joining RegSmart? Since I thrived for working with patient safety, I took the opportunity to join a consultancy company as a pharmacovigilance consultant.
23.10.04
Welcome to RegSmart, Sinéad Breen, senior consultant
In September, you joined the RegSmart team as senior consultant medical device and pharmaceuticals. What is your background, prior to joining RegSmart? Since qualifying as a Pharmacist many years ago the main focus of my career has been within the Pharmaceutical and MedTech industry.