Contract Research Organization

Your Nordic Contract Research Organization (CRO) and Regulatory service partner, with global reach

Offering a wide range of Services in Northern Europe and beyond for

From Concept & Strategy to Commercialization

Concept & Strategy

Getting it right from the outset will save both time and resources. Whether you are looking for regulatory advice, a workshop focused on your Target Product Profile (TPP), or assistance with your product’s Chemistry, Manufacturing, and Controls (CMC) documentation, we are here to help. We offer access to world-class senior Medical and Clinical Advisors through our Strategic Advice Group.

Development

Regarding the further development of your product, perhaps you need help with finding the right pre-clinical partner or auditing your pre-clinical partner. We can also assist with Good Distribution Practice (GDP), Quality Assurance (QA), help with Scientific Advice or perform a GAP analysis to make sure all documentation is in place for the clinical phase.

Clinical

Involves all from phase I to phase IV clinical studies. LINK Medical has established collaboration with several sites and Site network organizations for different indications and for different regions, including Key Opinion Leaders (KOLs). This means that start-up time is quicker. We can also discuss or provide input to your design and other market strategies.

Commercialization

Gather the package for your New Drug Application (NDA) with our Regulatory Department. Your product is on the market, now what? We at LINK Medical are also experts on activities to maintain the marketing authorization, like continuous Regulatory services, Marketing Compliance and Pharmacovigilance.
  1. Concept & Strategy
  2. Development
  3. Clinical
  4. Commercialization



Integrity

A strong Nordic culture underpins our high-quality service based on respect, work integrity and focus on solutions.



Agility & Flexibility

We have the flexibility to deliver the support you need, no matter how big or small your project.



Expertise

Our leading experts and technologies ensure we always follow industry advances and current regulations.



Comprehensive

We offer wide ranging services to pharma and medical device industries for your entire product development journey.

Our strengths

Why choose LINK Medical?

Become regulatory confident

The regulatory experts at LINK Medical can guide your company through the entire regulatory pathway. Additionally we can perform a GAP analysis to assure you have the right documentation to enter the clinical phase.

They are particularly well versed in the maintenance of marketing authorization of a product, label translations and marketing compliance.

Experts in clinical methodology for all phases

LINK Medicals employees are proud to be experts in the methodology of all clinical trial phases, regardless of complexity or indication. We have specially long experience from early oncology phase I studies. Additionally, we excel in handling the complex international phase II and smaller phase III studies, all with successful delivery and high quality through our adaptive and rigid processes.

Small enough and Big enough

We are the flexible contract research organization (CRO) with solid, established processes: not only are we agile enough to be adaptive to the needs of small customers but also big enough to handle complex international studies, including smaller phase III studies.

Why not engage LINK Medical as your local preferred provider for late phase studies?

Rigid processes with quality as a strong focus

Since we are audited several times each year by international companies, both big pharma and smaller companies, we constantly receive feedback on our Standard Operating Procedures (SOPs). Consequently, we are confident that we are up to date with all the latest requirements and regulations.

LINK Medical

Your Trusted Strategic CRO and Regulatory Partner

LINK Medical is a leading Contract Research Organization and Regulatory service provider offering experts, flexible services, and innovative technologies across Northern Europe and beyond. Additionally, our transparent Nordic culture provides a high-quality service delivery based on respect, work integrity and a strong focus on solutions.

590 +

clinical trials

150 +

employees

20 +

therapeutic areas

6

countries

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How can we help you?

Contact us and we will tell you more