Submit offer Regulatory Assessment and Commercialisation Support for the ExoGenis Microneedle Platform

    1. GENERAL INFORMATION:  

Titel of tender:  Regulatory Assessment and Commercialisation Support for the ExoGenis Microneedle Platform

Your company’s name:   ExoGenis ApS

Address: Ny Carlsberg vej 80

CVR nr.: 42109908

Date: 1st July 2026

Deadline for tender: 15th July 2026

For further questions: Irina Torres, Co-Founder & CEO

Mobile: 4553576004

E-mail: info@exogenis.sg

2. PRESENTATION OF COMPANY:  

ExoGenis ApS is a Denmark-registered biotechnology company developing microneedle technologies for dermatology and aesthetic applications. The company is progressing its technology towards commercialisation through technical development, regulatory planning and pilot validation.

The current development strategy consists of two parallel tracks. The first focuses on a near-term commercial pilot using an existing third-party manufactured microneedle product. The second focuses on the continued development of the proprietary ExoGenis microneedle platform for future biologic delivery applications.

As part of this process, ExoGenis requires external regulatory expertise to support key product development decisions and establish an appropriate regulatory pathway for both near-term commercial activities and future platform development. Website www.exogenis.tech 

3. DESCRIPTION OF THE TASK UNDER MARKET EVALUATION:  

The purpose of this assignment is to provide practical regulatory guidance supporting the next stage of development and commercial planning for the ExoGenis microneedle platform.

The assessment should address the regulatory considerations associated with both the proposed near-term commercial pilot using a third-party manufactured microneedle product and the continued development of the proprietary ExoGenis platform.

The work should identify the applicable regulatory framework, clarify the principal compliance requirements, assess key regulatory risks, identify documentation required before commercial activities, and provide recommendations to support future regulatory and commercial decision-making.

Deliverable

A concise written regulatory assessment providing:

an evaluation of the proposed regulatory approach for the planned commercial pilot;
identification of the principal regulatory obligations and documentation requirements;
guidance on regulatory considerations affecting product positioning, labelling and claims;
a high-level assessment of the regulatory considerations relevant to future platform development; and
recommendations for subsequent regulatory activities and key decision points.

4. TASK OBJECTIVES AND SUCCESS CRITERIA:  Objective

To obtain an independent regulatory assessment that supports strategic product development and commercialisation decisions while reducing regulatory uncertainty before implementation of pilot activities.

Success Criteria

The assignment will be considered successfully completed when the supplier delivers a written assessment that:

addresses the agreed scope of work;
provides clear and practical regulatory guidance;
identifies the principal regulatory considerations and compliance requirements;
supports informed decision-making for both near-term and long-term product development; and
includes recommendations for future regulatory activities.

5. BUDGET OG SPECIFICATION OF AN OFFER:  

The available budget for this assignment is approximately DKK 20,000 (excluding VAT).

The offer should include:

date of submission;
company presentation, including CVR number and contact details;
description of the proposed approach;
expected deliverables;
project timeline;
total fixed price or capped fee;
any assumptions or exclusions.
Optional activities outside the requested scope should be presented separately and will only be undertaken following written approval from ExoGenis.

6. BACKGROUND FOR THE TENDER:  ExoGenis has previously completed an initial regulatory product qualification assessment that identified the technology as a potential borderline product depending on its intended purpose, technical characteristics, product claims and supporting evidence.

Since completion of that assessment, the company's commercial strategy has evolved. The immediate priority is to evaluate the regulatory requirements for a clinic-based pilot using an existing third-party manufactured microneedle product while continuing the longer-term development of the proprietary ExoGenis platform.

Accordingly, the purpose of this procurement is not to repeat a general classification assessment but to obtain practical regulatory guidance that supports implementation planning, identifies regulatory requirements and documentation needs, and provides a clear basis for future development decisions.

Beyond Beta requires documentation demonstrating that external services have been procured on market terms. This tender forms part of that procurement process. The successful proposal will be selected based on the best balance between quality, relevance of the proposed approach and price.