info@biotrack.dk • Ulla Jessen: +45 29123040 • Ann Christine Korsgaard: +45 25403000

Regulatory Strategy and Execution

Exact and detailed knowledge about the possibilities and barriers in the regulatory field is a prerequisite for any drug development. We partner with you to understand your vision and ambition and prepare a bespoke regulatory strategy that match your ambition. This includes developing or revisiting the target product profile, bridging strategies, and clinical development program outlines. The regulatory strategy will reveal gaps and suggest opportunities for risk mitigation.

We will advice on how and when to engage with the regulatory authorities. Productive interaction with them gains trust to your project, and it is a key factor for efficient progress. We have extensive experience from all phases of drug development and we know the difference from nice to have and need to have. We help you execute your strategy by compiling and submitting dossiers to apply for orphan designation, protocol assessment, special status (for example PRIME, SME, Fast Track, Accelerated Approval, Breakthrough Status) and many more.

Interaction with Health Agencies

Seeking advice from regulatory agencies adds great value to your project as it let you into their current thinking and enables you to make timely adjustments to strategy and tactics. The authorities’ sanity check of your plan increase trust in the project and ensure you are on the right track. The regulators are keen on helping you. It may however be a challenge to figure out when it’s the right time to reach out and how to interact in a productive way.

We have hands on experience in communicating with regulatory agencies throughout the world both nationally (for example the national European agencies, Russia, Turkey, and Japan) and with the EMA and FDA. We help you phrase the questions, prepare the justifications and briefing package, arrange the meeting on your behalf and participate to orchestrate the meeting for you. Finally, we interpret the response and suggest possible actions to be taken based on the advice.

Clinical Trial Applications

Compilation of a clinical trial application (CTA or IND) often involves parallel processing of many different documents with contribution from various subject areas. Efficient project management, proven methodology and hands on experience will make this process less painful. Biotrack brings it together by providing seamless collaboration between medical writing and regulatory affairs. On top of this; we ensure efficient coordination of expert contributors, activities and documents. Our services include regulatory input to trial protocols, writing of trial protocols and investigator’s brochure, coordination and management of cross functional teams of contributors, compilation of IMPD, writing of draft informed consent etc.

Marketing Applications

To progress your asset you need to communicate your data and positions for regulatory confirmation. Planning and compilation of submission dossiers is often a huge undertaking involving cross functional teams of subject matter experts and contributors and it takes experience and method to prevail. Biotrack has led teams through to successful regulatory approval many times before and can help lead your submission as well as prepare parts of it for example the clinical study reports and Module 2.5 and 2.7 documents.

Medical writing

Biotrack manage and write protocols, clinical study reports, Investigator’s Brochure, meeting requests and briefing books, documents for submission in relation to applications for marketing authorisation (MAA, NDA, BLA, and variations) and much more.

Planning and Decision Making Tools

Target Product Profile, Clinical Development Plan, Project Plans and more
A target product profile (TPP) is essential to have a clear understanding of your intentions with the development plans. It points to your desired destination and the data you need to reach it. Whether you already have a target product profile or a clinical development plan which just needs some scrutiny from a regulatory point of view or you are about to start from scratch - we can help. We offer a strategic mindset fitted for biotech, tactical adroitness, and the hands and heads to glue it all together and prepare the documents. Biotrack may help you prepare a project plan or give you a second opinion on the one you have and provide you with a risk assessment and a gap analysis from a regulatory point of view.

Project management

The ability to keep momentum and secure progress is crucial when it comes to keeping your promise and reaching the next milestone. An objective is not achieved until all the subtasks are finished and therefore even the production of an Investigators Brochure (IB) to make the Clinical Trial Application (CTA) complete, benefits from efficient management of the various contributors and reviewers. Biotrack has skills and expertise to handle initiation, planning, execution and closing of your projects and task and we will make sure all contributors are connected and aligned in the plan towards your target.

Interim management

Interim management is a flexible solution when dealing with unforeseen business opportunities, implementing new projects, managing change projects, or filling a management gap during times of change. When you onboard an executive for a limited period of time it allows you to keep momentum or to leapfrog. You simply pay for the management hours you need - when the job is done you don’t have an expensive executive in your staff. Biotrack provide strong competencies and extensive experience and our management style has successfully been proven in our previous roles as vice president, line manager, and project manager/director.

Whether you need a manager for a limited period of time or for a specific project, Biotrack deliver general management, project management, and change management. As interim managers we contribute with professional competence and knowhow and may assume the role as a decision maker and not only as an advisor.

Scientific Communication

Manuscripts and posters
All scientists are faced with the pressure to publish their results in prestigious journals or scientific conferences and all face challenges when trying to write and publish. To develop good manuscripts for publication, abstracts, or poster requires integration of scientific skills, language skills, coordination skills and graphic design. Biotrack provides a framework for the efficient production of scientific communication and if needed, our associated graphic designer creates illustrations that support the message and ensures professional appearance.

Training and Crash Courses

Ann Christine Korsgaard and Ulla Jessen lectures at Medicademy and offers targeted training in best practice for the following topics:

  • Target product profile
  • Regulatory Strategy
  • Meeting with Health Authorities including rehearsals
  • Considerations for First in Man trials
  • Clinical trial applications
  • Compilation of INDs
  • Paediatric requirement (PIP and PSP)
  • Clinical Development Plan
  • Clinical Study report
  • Compilation of Marketing Application Authorisations

Templates and Methodology

Documents intended for regulators or the scientific community must live up to conventions set out in guidelines, instructions, and regulations. Using good templates with well crafted boilerplate passages, is a cost efficient method of preparing documents which is easy to navigate and lives up to expectations. This enables you to focus your energy on the scientific content rather than on the form. Biotrack has a set of standard templates which we adapt to our customers’ needs. We have a structured approach and a proven method for developing high quality documents fit for purpose and ensuring efficient review processes.

Counselling

One on one sparring
A good sparring partner, who is willing to invest her mind and heart, is necessary for you to develop optimally. You need someone who can give you a different perspective and see yourself from “outside”. someone to help you leave daily operations behind and focus on long term goals to make them happen – for you as a professional and a leader. A mentor sequence creates room and time to give the mentee sparring on work life and career. Our core competences are within the fields of relationship building, career development, strategic and personal leadership development.

Facilitation of workshops
Workshops can be a productive way of turning thoughts into action. The key is to make sure the output is optimal so it makes the time well spent. This requires focus and prioritisation in your busy everyday job. Whether you plan a workshop to develop for instance a paediatric strategy or you need a facilitator to connect your team and improve performance, Biotrack can step in to ensure focus and lead you through the logistics and content of the workshop. Leave it all to us so you can make the best of the workshop.

Due diligence

You may want to evaluate another company’s asset or you may want to find a partner or buyer of your asset. In both situations a Due Diligence’ is required. Biotrack can help you evaluate options through this process as well as prepare you to be evaluated by others. Our extensive regulatory experience has provided a frame for understanding the Due Diligence situation from both sides. We know how to best prepare for a Due Diligence to “pass the exam” of someone evaluating your product. We know how to assess a dossier for regulatory usage.