Submit offer US Regulatory Strategy and FDA Q-sub Preparation

Template for the Task Description
  
A good Task Description must include the following:  
 
1. GENERAL INFORMATION: 
Titel of tender: US Regulatory Strategy and FDA Q-sub Preparation
Your company’s name:  MultiBiopsy
Address:  Universitetsbyen 76, 8000 Aarhus C, Denmark

CVR nr.:  44304554
Date:  28.04.2026
Deadline for tender:  26.05.2026
For further questions, contact info:  William Ludvigsen, CEO
Upload of tender info: Use link in task description
Phone and e-mail:  William.Ludvigsen@multibiopsy.com 
tlf: +45 40106428
 
2. PRESENTATION OF COMPANY: 

MultiBiopsy is a Danish early-stage MedTech company developing an innovative biopsy device for soft-tissue cancer diagnostics. The company is developing a biopsy pistol capable of retrieving multiple tissue samples from a single insertion, with the aim of improving diagnostic accuracy, lowering complication risk, reducing re-biopsy rates, and fitting naturally into current interventional radiology workflows.

The company combines clinical, engineering, and regulatory competences and has already developed a proof-of-concept needle system together with external manufacturing and development partners. MultiBiopsy is currently focused on maturing the technology, strengthening its documentation package, and preparing a robust market access and regulatory pathway for future commercialization.

 
3. DESCRIPTION OF THE TASK UNDER MARKET EVALUATION: 

MultiBiopsy seeks an experienced regulatory consultant or regulatory team with documented MedTech experience to support the company's competence development related to FDA market access planning.

The task focuses on advisory support and structured preparation for early regulatory dialogue with the U.S. Food and Drug Administration (FDA), with emphasis on preparation for a future 510(k) pathway, predicate device strategy development, and readiness for a potential Q-Submission process.

The primary purpose of the task is to prepare MultiBiopsy to engage with the FDA in a well-informed and structured manner, ensuring that required testing, documentation, and strategic decisions are planned correctly from the outset. A key objective is to reduce the risk of regulatory missteps, incomplete preparation, or poorly framed FDA questions that could lead to delays, rework, or long-term regulatory challenges.

The consultant is expected not only to provide strategic guidance, but also to educate the MultiBiopsy team in how FDA preparation should be conducted in practice. This includes teaching the company how to plan regulatory activities, structure documentation, assess testing needs, and prepare regulatory questions, so the company can continue the work internally after the consultancy.

The task should include:

•             Review MultiBiopsy's current device concept, intended use, technological characteristics, and current development maturity relevant to a future FDA pathway. 

•             Assess likely regulatory pathway assumptions and support an initial 510(k) strategy discussion, including possible product code, classification assumptions, and predicate device mapping logic. 

•             Explain how predicate device selection and substantial equivalence logic should be evaluated, including how to document rationale and alternatives. 

•             Advise on what testing, evidence, and documentation should be planned prior to FDA interaction, including identification of critical gaps, risks, and sequencing dependencies. 

•             Support development of a structured preparation approach for an FDA feedback interaction, including guidance on how to design testing strategies that align with anticipated FDA expectations. 

•             Support drafting or structuring selected briefing materials for an FDA feedback dialogue and/or a future Q-Submission package. 

•             Help prepare well-defined and strategically relevant questions for FDA, particularly those that can reduce uncertainty related to substantial equivalence, performance testing, usability, risk management, and clinical expectations. 

•             Provide structured guidance on how to interpret FDA feedback and translate it into actionable development decisions. 

•             Facilitate knowledge transfer to the MultiBiopsy team through workshops or working sessions focused on regulatory planning methods, documentation strategy, and regulatory decision-making. 

•             Deliver a concise written output summarizing recommended next steps, documentation priorities, testing considerations, assumptions, open issues, and a suggested step-by-step pre-submission roadmap.

4. TASK OBJECTIVES AND SUCCESS CRITERIA: 

The goal of the task is to strengthen MultiBiopsy's internal regulatory competencies and significantly improve the quality of the company's preparation for future FDA interactions.

A satisfactory outcome should reduce uncertainty around the future 510(k) pathway and provide MultiBiopsy with a clear, practical, and actionable plan for preparing the correct documentation, testing strategy, and regulatory questions before entering a formal FDA feedback process.

The task should also strengthen the company's ability to independently manage regulatory preparation and avoid missteps that could result in unnecessary testing, delayed approvals, or regulatory setbacks.

Success criteria include:

•             MultiBiopsy receives a clear written assessment of the most plausible 510(k)-relevant regulatory route and its key assumptions. 

•             A structured predicate device strategy is developed, including documented rationale, potential alternatives, and identified uncertainties. 

•             A prioritized regulatory gap overview is delivered covering documentation, testing, performance validation, usability considerations, and evidence requirements prior to a Q-Submission. 

•             Draft structure or annotated content is produced for the key components required for an FDA feedback package or Q-Submission preparation. 

•             The consultant provides structured guidance on how to plan testing activities in alignment with regulatory expectations, reducing the risk of unnecessary or misaligned testing efforts. 

•             At least one structured knowledge-transfer session is completed with the core team, ensuring that MultiBiopsy gains practical competence in preparing regulatory materials and managing FDA preparation activities independently. 

•             The final output includes a detailed step-by-step action plan with clearly prioritized next actions, recommended sequencing, responsibilities, and key decision milestones. 

•             MultiBiopsy gains improved internal confidence in preparing FDA interactions and interpreting regulatory expectations in a structured and risk-aware manner.

5. BUDGET OG SPECIFICATION OF AN OFFER: 
We expect a written offer to include at least: 
• Date of submission of offer 
• A brief presentation of the bidder, stating the CVR number and contact details. If relevant, with references and history 
• Bidder's proposal for solving the task 
• Specification of the price for solving the task 
• Discount, if relevant 
• Timeframe and end date 
• MultiBiopsy requests a written offer for the advisory and competence-building task described above. The service must be limited to analysis, guidance, documentation support, strategic planning, and capability building. Execution or implementation services beyond advisory support are outside scope.

Additional expectations for this tender:

•             Demonstrate direct experience with FDA regulatory strategy for medical devices, preferably Class II devices and 510(k) processes.

•             Clarify whether the bidder has experience preparing or supporting Q-Submissions and early FDA dialogue.

•             Describe how the bidder will ensure knowledge transfer to MultiBiopsy rather than only delivering a consultant memo.

•             Specify which senior experts will participate directly in the task.

•             Preferably have experience with Danish MedTech Start-ups. 

 
6. BACKGROUND FOR THE TENDER: 
Beyond Beta is subject to a number of requirements for good, healthy financial management, including documentation that the agreed price for external purchases is an expression of the market price. This tender is part of these requirements. 
We emphasize that the bidder must only make an offer on the requested task.  
Services of executing or implementing nature cannot be approved  
The winning bid is chosen based on an assessment of the best correlation between price and quality