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Early Development

Early Development Support: Getting it right. The first time


We know that the right development strategy for your product is critical from the very beginning to ensure an efficient pathway towards the market. Therefore, we provide a strategic partnership where we assess and understand your risks, offering planning and advice to cut time, costs and wasted resources in product development. From designing your Target Product Profile to submitting clinical trial applications, we offer full and flexible service solutions, and our specialist team will actively communicate with you to customize the services according to your company’s specific needs. LINK Medical services will empower your decision-making throughout the process and lay the groundwork for a smooth product development.

Target Product Profile (TPP) consultancy and workshops

We help you outline the strategy for your product to enter the market by highlighting the clinical development and regulatory plans required, as well as performing production and Chemistry, Manufacturing and Controls (CMC) planning. Our one-day TPP workshops have been a resounding success with clients as a quick and to-the-point support that helps propel their further product development.

Regulatory support
With one of the largest regulatory teams in Northern Europe, we can help you clear every regulatory challenge with confidence. We offer a variety of early development services and support including regulatory planning, gap analysis to ease clinical trial application submission, scientific advice, CMC, preparation of the IMPD, and compilation of the Regulatory Package. Read more about our full regulatory services.
Quality Assurance support
The importance of early quality management is crucial to successful product development. We will build and maintain your Quality Management System (QMS), and support your company in audits (vendor, QMS and systems). Read more about our full quality assurance services.
Medical Support
Our medical officers will fully support you throughout the planning phase of your clinical trial. These officers are also on-hand at our TPP workshops, offering specialist medical expertise that helps inform and accelerate your product development.
Project Management
Our project management services can include providing you with a hand-picked expert who will drive all pre-clinical activities to agreed timelines and foster proactive team management, as well as coordinate the compilation of documentation necessary for the clinical trial. Read more about our full project management services.
Medical Writing
Our team of medical writing experts can support the production of key early development documents, and can also summarize the CMC and non-clinical pharmacology and toxicology data. Read more about our full medical writing services.
Business plan
We can support your market and financial planning, including reimbursement planning. We also offer advice on due diligence processes and on how to attract investors.

Business area head:

Yngve Mikkelsen
Executive Vice President Medical Operations

Yngve graduated from medical school in 1991 and in addition, holds a Master of Management degree from the Norwegian Business School (BI). Before joining LINK Medical as Chief Medical Officer and Director for Real World Evidence and Health Economics, he served in various vice president roles in the clinical sector. At LINK Medical, he is directly involved in expertly managing health economic evaluations and reimbursement applications.

yngve.mikkelsen@linkmedical.eu

“The TPP workshop gave us an excellent, clear understanding of the regulatory pathway. Having experts from different areas of the health care sector in the same room, answering all our questions, was a fantastic benefit for us”

Mohamad Takwa, CEO Thyrolytics

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