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Early Clinical Development

Getting it right from the start

We know that the right development strategy for your product is critical from the very beginning to ensure an efficient pathway toward 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.

In the very early days of developing a product, it can be difficult to understand what questions to ask in order to shape the product profile and develop a starting point for the development of the product. That is why we offer a free one to two-hour meeting with our Strategic Advice group which is led by our Medical Director and experienced people in Clinical Development, Medical Writing, Quality, Regulatory, Statistics, and Business Development. We offer a free consultation for new customers, the consultation is for a general Scientific advice session to chisel out initial areas to clarify, and help in formulating the questions that will help take your product further.  Contact us using the form in the Strategic Group tab below to schedule your initial meeting free of charge.

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 smooth product development.

Strategic Advice Group:

Meet the Strategic Advice team:

  • Rikard Reneland, Medical Director, Clinical Development, Coordinator
  • Hilde Holme, Regulatory, CMC
  • Malin Schollin, Statistics
  • Gunnar Danielsson, Senior Regulatory Advisor
  • Magnus Ringbom, Medical Writing, Project Management
  • Michael Hakenäs, Business Development

Schedule your Strategic Advice appointment here

Fill in the form below and we will set up the best team for a free consultation.

    Request for initial meeting with LINK Medical’s Strategic Advice Group
    One meeting of 1-2 hours duration free of charge. The LINK Medical team will be set up based on the need.




    Class of product

    Purpose of consultation

    Briefly state some background, at what stage you are in, and what decision(s) you are trying to make.

    Submit your questions:

    Please limit your questions to 4 or less.

    Requested time slot for consultation

    Please add two time alternatives below and allow 2 weeks’ lead time from the request. LINK Medical reserves the right to propose another time slot for the meeting.




    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.
    Scientific Advice
    Scientific advice helps to ensure that our sponsors perform the appropriate tests and studies, so that no major objections regarding the design of a clinical study are likely to be raised during the evaluation of the Clinical Trial Application and later the Marketing Authorisation Application. This also helps avoid patients taking part in studies that will not produce useful evidence.

    Our team has extensive experience advising our clients about the most appropriate way to generate robust evidence on a medicine’s benefits and risks. For a medicine to be authorised, medicine developers have to demonstrate that it is effective, safe and of good quality.

    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.

    Contact us!

    Johanna Sundberg
    Executive Vice President,
    Clinical Development
    Johanna holds a PhD in toxicology and has over 20 years’ experience within research and the CRO industry, working extensively within phase I-II studies and associated project management. Johanna has been part of the Uppsala team since in September 2015 with different management roles including Director of Project management. Prior to that, she transferred from Quintiles where she held the position of Director, Clinical Project Management. Today Johanna is the VP of Clinical Operations where she supports Nordic teams as an international leader.

    Contact via email

    “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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