Membership

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.

Catalent

Catalent is the leading global provider of advanced delivery technologies, development, and manufacturing solutions for drugs, biologics, cell and gene therapies, and consumer health products. With over 85 years’ industry experience, Catalent has the proven expertise, superior technologies and flexible solutions at the right scale to help ensure successful product development, launch, tech transfer and reliable global clinical and commercial supply. Our team of approximately 15,000 people, at +45 sites, supplies over 73 billion doses of +7,000 products for more than 1,000 customers – or 1 in 20 doses taken by patients globally. At Catalent, we combine deep expertise in the science of drug development and manufacturing with the art of crafting better treatments to deliver successful medicines for our customers and their patients faster.

Catalent, where science meets art.

Alfa Laval

The Alfa Laval Group is a leading global supplier with high-quality products based on three core technologies of heat transfer, separation and fluid handling. Alfa Laval is active in the areas of Energy, Marine, Biotech and Pharma as well as Food & Water treatment, offering its expertise, products and service to a wide range of industries in over 100 countries. The company is committed to optimizing processes, creating responsible growth, and driving progress – always going the extra mile to support customers in achieving their business goals and sustainability targets. Alfa Laval’s innovative technologies are dedicated to purifying, refining, and reusing materials, promoting more responsible use of natural resources. They contribute to improving energy efficiency and heat recovery, better water treatment, and reduced emissions. Thereby, Alfa Laval is not only accelerating success for its customers, but also for people and the planet. Making the world better, every day. It’s all about Advancing better™.

In Denmark, Alfa Laval has five companies, all owned by Alfa Laval Corporate AB, which is listed on Nasdaq OMX and is headquartered in Lund in Sweden. Alfa Laval has approx.17,500 employees worldwide.

www.alfalaval.com / www.alfalaval.dk.

CP Kelco

CP Kelco is a nature-based ingredient solutions company with over 85 years of experience working with food, beverage and consumer and industrial products manufacturers worldwide. We unlock nature-powered success by applying ingredient innovation and problem-solving to develop customized solutions that leverage our regional insights and meet manufacturers’ goals to address consumer needs and preferences.  What sets us apart:

• Unique Portfolio. Produces extensive range of high-quality, plant-based and fermentation-derived ingredients to formulate tailored solutions.
• Technical Excellence. Offers strong collaboration with a global team of scientists and applications experts, leveraging our regional state-of-the art R&D facilities.
• Sustainability. Committed to providing responsibly sourced and produced ingredients.
• Market Insights. Understands market and consumer trends to help customers create relevant and innovative products.

Our key product lines include gellan gum, pectin, xanthan gum, carrageenan, diutan gum, fermentation-derived cellulose, refined locust bean gum, microparticulated whey protein concentrate and our latest innovation, NUTRAVA™ Citrus Fiber. Learn more at www.cpkelco.com.

Bristol Myers Squibb

Bristol Myers Squibb Company is a global biopharmaceutical company, headquartered in New York City with 30,000 employees globally. Our mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. Bristol Myers Squibb focuses its research efforts in the areas of oncology, hematology, immunology, cardiovascular – and fibrotic diseases; all of which are areas of high, unmet medical need. We are proud of the advancements we have made in these particular disease areas, and we are dedicated to helping patients prevail over serious diseases through our diverse and promising pipelines and new scientific platforms.

Bristol Myers Squibb is a differentiated company, led by our unique biopharma strategy that leverages the reach and resources of a major pharma company paired with the entrepreneurial spirit and agility of a biotech firm.

From 2008 to 2017, Bristol Myers Squibb invested directly in seven different Danish companies (mostly biotech companies), equaling a total amount of more than USD 1.7 billion (approximately 12 billion DKK), making Denmark the country that attracted the most investments outside the US during 2008-2017, both in numbers of investments and in monetary terms.

Bristol Myers Squibb has engaged in very significant partnerships and collaborations throughout the years, contributing to the thriving Danish life science industry. The investments made from 2015 to 2017 make Bristol Myers Squibb one of the biggest foreign investors in Denmark overall.

In November 2019, Bristol Myers Squibb completed the acquisition of the Celgene Corporation. The acquisition valued at 90 billion USD is one of the largest acquisitions in the history of the pharmaceutical industry. The combination of the leading science, innovative medicines and talent of both Bristol Myers Squibb and Celgene created a leading global biopharma company that continues to deliver highly advanced and innovative medicines for patients with serious diseases.

Quotient Sciences

Quotient Sciences has over 30 years of experience in small molecule drug development, supporting clients from candidate selection to commercial supply. We’re experts in formulating simple and complex oral and inhaled drug products, with a broad range of manufacturing technologies and high-potency handling capabilities.

Our services include: Formulation Development, Clinical Trial Manufacturing, Commercial Manufacturing, Clinical Pharmacology, and Translational Pharmaceutics®, which accelerates development by integrating formulation development, real-time manufacturing and clinical testing. Connect with Quotient Sciences to discover how we can accelerate the development of your molecule.