Submit offer Regulatory Classification & Claims Substantiation Dossier – ExoGenis Microneedle Platform

 1. GENERAL INFORMATION
Title of tender: Regulatory Classification & Claims Substantiation Dossier – ExoGenis Microneedle Platform

Company name: ExoGenis ApS

Address: Ny Carlsberg vej 80

CVR nr.: 42109908

Date: 25th February 2026

Deadline for tender: 14 days from issue

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

Mobile: 4553576004

E-mail: info@exogenis.sg

2. PRESENTATION OF COMPANY

ExoGenis is a biotechnology skincare startup developing a dual-phase dissolvable microneedle platform designed to deliver fragile biologics (including extracellular vesicles and peptides) into viable epidermal layers. The  company operates with a B2B-first strategy targeting aesthetic clinics in the Nordic region and EU markets. ExoGenis has filed a provisional patent (SG 10202501758P) covering its dual-phase delivery mechanism and is currently preparing for pilot testing with clinical partners. The company’s near-term objective is to ensure full regulatory alignment under EU cosmetic regulation while preserving future optionality toward therapeutic pathways.

ExoGenis is preparing for pilot execution in clinical settings and an external funding round. Due to the innovative nature of microneedle delivery of biologically active components, clear regulatory positioning is critical. This tender is issued in accordance with Beyond Beta requirements to ensure documentation of market-based pricing for external advisory services. Only advisory and documentation services are requested. Implementation services will not be part of this engagement.The winning bid will be selected based on the best balance between price and demonstrated regulatory expertise in cosmetic-biotech products.

Website: www.ExoGenis.sg

3. DESCRIPTION OF THE TASK UNDER MARKET EVALUATION

ExoGenis seeks to engage an external regulatory affairs consultant with documented experience in EU cosmetic legislation and borderline cosmetic-biotech products. The task is to de-risk ExoGenis regulatory positioning prior to clinical pilot launch and funding found. . The scope of work includes development of a structured Regulatory Positioning Dossier (10–15 pages) covering:

A. Regulatory Classification Memo: Including a formal assessment of classification under EU Regulation (EC) No 1223/2009, Assessment of EU and UK regulatory positioning, Borderline analysis (cosmetic vs medicinal product vs medical device) and a written  justification supporting cosmetic classification.

B. Claims Substantiation Framework: Structured list of legally permissible claims categories; identification of high-risk wording to avoid, as well as mapping of current scientific evidence to proposed claims and the identification of additional data requirements for substantiation.

C. CPSR & Product Information File (PIF) Roadmap

Required ingredient documentation overview:

·      Safety data requirements

·      Stability, microbiological, and toxicology considerations

·      Structured roadmap toward CPSR readiness

D. High-Level Therapeutic Pathway Outline

This includes the overview of regulatory changes required if repositioned toward medical indication and Identification of major data gaps with strategic guidance for preserving future regulatory optionality. The deliverable must be structured as a professional dossier suitable for investor and partner due diligence.

Success criteria:

·      Written confirmation of regulatory classification under EU cosmetic framework

·      Clear written guidance on permissible claim language

·      Defined roadmap for CPSR compliance

·      Identification of key regulatory risks

·      Deliverable formatted for investor-grade documentation

The task is considered successfully completed upon delivery of the structured Regulatory Positioning Dossier.

4. BUDGET AND SPECIFICATION OF OFFER

Expected total budget: DKK 43,000 (excl. VAT)

Budget breakdown (indicative):

Regulatory classification memo: DKK 18,000

Claims substantiation framework: DKK 12,000

CPSR documentation roadmap: DKK 8,000

Therapeutic pathway outline: DKK 5,000

We request that bidders submit a written offer including:

Date of submission

Company presentation incl. CVR and references

Proposal for solving the task

Detailed price specification

Timeline and end date

Any conditions for the offer

Expected timeframe for completion: 4 weeks from contract signature.