Membership

Phystec

Phystec develops and supplies products, for the Health Care sector, that increases mobilization and activity in patients. Phystec’s vision and products are aligned with and contributing to the Swedish government’s vision of e-Health 2025.

LINK Medical

LINK Medical is a full-service contract research organization (CRO) providing product development services for the pharmaceutical and medical device industries across Northern Europe. We offer a well-integrated local presence in the Nordics, UK, and Germany. Reaching from early phase development to post-marketing, we provide expert guidance across every aspect of a project – all from ONE source. As a strategic partner, we provide expert competence and technology to enable evidence-based decision-making that support the delivery of superior clinical outcomes.

Thermo Fisher Scientific

Thermo Fisher Scientific Inc. is the world leader in serving science. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing productivity in their laboratories, we are here to support them. Our global team of more than 80,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services and Patheon. For more information, please visit www.thermofisher.com.

SDS LIFE SCIENCE AND SDS MEDTEQ

Consultants in Drug Development, Device Development, Regulatory, Clinical Project Management and Biostatistics

In SDS, SDS Life Science and SDS MedteQ, we are specialized in regulatory and scientific knowledge in drug development, medical device and statistics. Our ambition is to guide our clients in transforming their research hypotheses into full clinical studies.

We provide expert advice on formulation development, planning of both clinical and non-clinical programs, as well as medicinal product development. Our experienced project managers can provide all the required support and oversight of activities for the program, including writing the protocols and technical documentation. We have experts in writing high quality clinical reports that meet the authorities’ standards. Our trusted team of regulatory experts can act as communication mediators with the regulatory authorities, such as Notified Bodies.

In collaboration with our regulatory experts, our accomplished statisticians adopt a holistic approach to help our clients to conduct statistically well-designed studies in accordance with the regulatory standards. Taking advantage of SDS strong expertise in medicinal products, medical device and biostatistics we can expand our services to combination products (drug-device/biologics-device), medical devices for in-vitro diagnostics or to products for which the applicable regulation is not well-defined.

We are passionate about solving those tricky questions which have no obvious answers. We always stay curious, and we always strive to update our scientific knowledge. We have it all!

SDS Life Science: https://sdslifescience.com/
SDS MedteQ: https://sdsmedteq.com/

Pharma Intelligence

Trusted by over 3,000 of the world’s leading pharmaceutical companies, CROs, med and biotech organizations, and consumer healthcare organizations, the Pharma Intelligence suite of intelligence solutions delivers vital, accurate, and timely intelligence about the drug development pipeline to pharmaceutical and biomedical decision makers around the world.

At Pharma Intelligence, global teams of subject area experts follow and analyze key diseases, clinical trials, drug approvals and R&D activities as part of the breadth and depth of data available to customers.

Systec & Solutions

Systec & Solutions is a specialized manufacturer of hardware solutions for the pharmaceutical, cosmetics and food industry as well as for hospitals to name a few. Our products have been utilized by nearly all established pharmaceutical companies for years.

GMP-IT – Industry-compatible & durable
Regulated industries comply to GMP standards and our GMP-IT hardware systems are fully equipped to meet the challenges. An uncompromising industrial design, employing only industry-grade components, guarantees highest quality and long-term availability.

Cleanroom-compatible & highly efficient
All of our systems are fully encapsulated and IP65 rated. They are easy to clean and satisfy the hygiene requirements of the pharmaceutical, cosmetics and food industry.

Ruggedly constructed & compatible
Our systems and platforms are specifically developed for long-term operation in demanding production environments. They prove themselves in practice daily, dealing with vibration, shock, humidity, water or dust. They are retrofitable and upgradable, compatible with established hard- and software systems and are easy to integrate into the existing IT landscape. Our GMP-IT products are ideally suited to applications such as workstations for MES software, Distributed Control Systems (DCS) and ERP software, room status displays and the presentation of KPI and OEE figures.

Acorai

Acorai is developing an AI-based medical device that could become the first non-invasive monitor of blood pressure within the heart. The product combines novel sensor technologies with the patient’s mobile phone and is intended for use in the home environment by heart failure patients. It has the potential to sharply reduce the number of hospital readmissions for such patients.

Key2Compliance

We make complex things easier – all the way from idea to market – with focus on Life Science industry and complete solutions in all aspects of regulatory compliance. Development of medical devices and pharmaceuticals is a complex, demanding task and never a straight forward mission, especially when it comes to handle regulatory requirements. Further down the road of development, the products are eventually ready to be put on the market – which is yet another challenge.

Key2Compliance® is a full-service partner that you can Rely on during your journey. You can get support in all aspects of consultancy and training when it comes to Clinical Development, Biological Evaluations and Toxicology, Quality Assurance and Regulatory Affairs.

Current business areas

• Quality Assurance: Quality system, GXP, technical files, inspections, audits, PRRC responsibility and more
• Regulatory Affairs: Technical files and other Documentation and CE markings, FDA approvals and registrations, access to other markets, UK responsible person
• Biological Evaluations and Toxicology: Biological evaluation, material documentation, recommendations, reports and more
• Clinical Development: Clinical evaluations, prospective clinical studies, performance evaluations for IVD and post marketing studies.
• Training and Courses: World-leading training for Pharmaceutical and Medical Device companies

Key2Compliance® will be your partner – Rely on us

MedVASC

The Company was established in 2013 by Dr Michael Åkesson to pursue his invention improving the procedure of minimally invasive treatment in the condition of varicose vein. With the plan to capitalise on a medical device, and after extensive research and development work the company filed for a patent in 2015 which was granted and published in 2017.

The vision leading all company efforts now is to launch a market-winning product which will improve patients’ well-being, shorten the treatment procedure and provide security to doctors. MedVASC AB aims to make Solutio the standard for administering anaesthesia in varicose vein treatment. The company’s mission is to provide the most efficient and the safest treatment with minimum pain and maximum comfort to the patient.

QNTM Labs

QNTM Labs is establishing a state-of-the-art GMP-certified laboratory dedicated to supporting the development of the medical cannabis industry, with a dedicated focus on analytical healthcare services. We specialize in robust testing and analysis for regulatory compliance, world-class innovative research for pharmaceutical advancement, as well as scientific advisory and bespoke consulting.

Our mission is to build a foundation of medical cannabinoid excellence to bridge the gaps between cultivators, researchers, regulators, and other industry stakeholders as we drive laboratory modernization and foster responsible, informed development within medical cannabis ecosystems, globally.

QNTM Labs was founded in Denmark, but services broader European markets and has established strategic collaborations with forward-looking stakeholders both within the Medicon Valley region, as well as internationally. Connect with QNTM Labs to discover how we can explore further opportunities to work collectively to advance the development of cannabis-based pharmaceuticals and cannabinoid science.