• Ulla Jessen: +45 29123040 • Ann Christine Korsgaard: +45 25403000

Regulatory Affairs

In the heart of all drug development lies the desire for bringing good drugs to patients. This applies regardless of your short term goals. A regulatory strategy gathers all the threads and keeps you in control. It provides you with a viable approach for getting you through the regulatory maze and brings value to your asset whether your objective is to go all the way to market yourself, to secure partnership, or to sell the asset. The pathway to patients goes through the authorities’ approval. A regulatory strategy shows you how to involve them.

Biotrack integrate regulatory savvy to your business. We seek to understand your vision and prepare strategies and tactics which fit your business and goals. We work with you to identify possibilities and hurdles to be overcome and advice when to liaise with health authorities to find the best way forward. Also, we provide the execution power needed to keep momentum thereby reducing cost and time.

Medical Documentation

The refinement of data to create information and knowledge creates a biotech company’s biggest assets. Documentation and communication of medical research to regulators, investigators or to the market has to be efficient and fit for purpose. This requires a structured approach, ability to work efficiently with subject matter experts and decision makers, and knowledge of the audiences’ expectations. Good data is dependent on good communication tools to deliver maximum value.

Project Management

Start-ups and small businesses depend on outside professionals and interim executives. They can provide experienced guidance on what needs to be done and they can do the work. Most results come from the work of cross functional teams of individual contributors and it often requires substantial effort to streamline their work and ensure consistency and progress. Biotrack project managers bring certified project management skills and apply project management methods, techniques and tools to handle situations from a holistic perspective. We work on all organisational levels and pay attention to timely communication and adequate reporting.

Scientific Communication

To be successful depends on your ability to develop and deliver your message. You must know your song before you start to sing – and your audience, whether it’s fellow scientists or a collaborator. We offer proven methodology and skills in project planning and scientific communication as well as in-depth knowledge of regulatory perspectives to facilitate communication of the project plans strengths and weaknesses. Preparation of manuscripts and posters is time-consuming and tends to drop down on the to-do list as tasks of higher prioritisation continue to emerge. We provide an efficient method of getting you manuscript prepared and finalised, and collaborate with graphic designers to provide the professional appearance needed to convey the message efficiently.