Submit offer ExoGenis Intitial Regulatory landscape

 1. GENERAL INFORMATION:  

Title of tender: ExoGenis Intitial Regulatory landscape

Company name: ExoGenis ApS

Address: Ny Carlsberg vej 80

CVR nr.: 42109908

Date: 29th June 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 a dissolvable microneedle platform for the delivery of biologically active ingredients into the viable epidermis. The company is progressing the technology through technical development, regulatory planning and commercial validation to support future market introduction.

As part of its product development programme, ExoGenis is assessing the appropriate regulatory pathway for the platform under the European regulatory framework. The purpose of this tender is to obtain quotations for an independent regulatory product qualification and classification assessment to identify the most appropriate regulatory pathway, evaluate potential borderline classification issues and provide recommendations for future regulatory development.

3. DESCRIPTION OF THE TASK UNDER MARKET EVALUATION:  

The purpose of this assignment is to obtain an independent regulatory product qualification and classification assessment of the ExoGenis microneedle platform before further product development and pilot activities.

The supplier shall:

Review the ExoGenis product concept, intended purpose and available technical documentation.
Assess the product under the applicable European regulatory frameworks, including Regulation (EC) No. 1223/2009 on cosmetic products and Regulation (EU) 2017/745 on medical devices (MDR).
Evaluate the potential borderline classifications between cosmetic product, medical device, combination product and medicinal product.
Assess the principal classification factors, including:
intended purpose;
mechanism of action;
microneedle penetration depth;
epidermis/dermis boundary;
exosome-based active ingredient;
proposed product claims.
Identify the principal regulatory risks that may influence future product classification.
Prepare a written regulatory classification analysis summarising the findings.
Revise the report following comments from ExoGenis and issue a final version.
Deliverable

A written regulatory classification analysis including:

preliminary assessment of cosmetic versus medical device classification;
identification of the principal borderline risks;
discussion of the factors influencing future classification;
identification of the additional evidence required before a definitive classification can be established; and
recommendations for the next regulatory steps.
4. TASK OBJECTIVES AND SUCCESS CRITERIA:  Objective

To obtain an independent regulatory assessment that identifies the most appropriate regulatory pathway for the ExoGenis product concept and highlights the principal regulatory risks requiring consideration during product development.

Success Criteria

The assignment will be considered successfully completed when the supplier delivers a written regulatory classification analysis that:

evaluates the applicable regulatory framework for the ExoGenis product;
provides a reasoned preliminary classification assessment;
identifies the principal borderline classification issues and regulatory risks;
specifies the evidence required to support future regulatory decisions; and
provides clear recommendations for the next regulatory activities.

5. BUDGET OR SPECIFICATION OF AN OFFER:  The expected budget for this assignment is DKK 23,000 (excluding VAT, if applicable).

The offer shall include:

Date of submission.
Company presentation, including CVR number and contact details.
Description of the proposed approach.
Fixed price for the assignment.
Any applicable discounts.
Estimated completion timeframe.
Any conditions associated with the offer.
The assignment is limited to the regulatory product qualification and classification assessment described above.

The following activities are explicitly excluded from the scope:

Claims substantiation strategy.
Cosmetic Product Safety Report (CPSR) and Product Information File (PIF) planning.
Therapeutic regulatory pathway assessment.
Cosmetic pilot claims strategy.
Preparation of regulatory submissions or implementation activities.