HNN3.0

CLUSTER Health Horizon Europe Brokerage Event 2027

24 – 25 Nov 2026

Register
Register
Register

Project cooperationUpdated on 21 October 2026

Practical regulatory guidance - from concept to validation and to market

CEO & Business development at AMIQALY

Prague, Czech Republic

About

  1. AMIQALY establishes the regulatory pathway from the beginning of the project, so that regulatory requirements become development inputs rather than issues discovered towards the end.

This can cover:

  • product qualification and classification;

  • assessment of the applicable regulatory framework;

  • regulatory feasibility assessment;

  • definition of the anticipated regulatory pathway;

  • identification of regulatory evidence needs;

  • regulatory gap and readiness assessments;

  • regulatory strategy and planning throughout product development

2. Medical Device Regulation and IVDR support

AMIQALY publicly offers MDR and IVDR consulting, including:

  • medical-device and IVD classification;

  • regulatory strategy and planning;

  • technical-documentation review;

  • clinical and performance evaluation support;

  • regulatory gap assessments;

  • regulatory-readiness reviews;

  • post-market regulatory support.

This is particularly useful in Horizon Europe Health projects where a prototype is expected to progress towards a genuine medical-device or diagnostic product.

  1. Clinical and performance evidence strategy

  2. Quality Management and ISO 13485

  3. Digital health, SaMD and AI-enabled medical products

  4. Medicinal products and ATMPs

  5. Commercialisation and market-access preparation

  6. Regulatory input into exploitation and IPR strategy

  7. Regulatory risk management

  8. Regulatory roadmap towards post-project development

  9. Regulatory workshops and capacity building

  10. Regulatory support during proposal preparation

  11. Regulatory due diligence for project results

  12. Responsibility of a dedicated Regulatory Work Package

Topic

  • Destination 1: HORIZON-HLTH-2027-01-STAYHLTH-01: Addressing disabilities through the life course to support independent living and inclusion
  • Destination 2: HORIZON-HLTH-2027-01-ENVHLTH-MISSCLIMA-03: Tools and technologies to support health adaptation to climate change
  • Destination 3: HORIZON-HLTH-2027-01-DISEASE-05: Development of novel small molecule antiviral therapeutics for pathogens with epidemic potential
  • Destination 3: HORIZON-HLTH-2027-01-DISEASE-06: Development of monoclonal antibodies to prevent and treat infections from Flaviviruses
  • Destination 3: HORIZON-HLTH-2027-01-DISEASE-07: Development of monoclonal antibodies to prevent and treat infections from Filo-, Nairo-, Phenui-, Picorna- and Toga viruses
  • Destination 3: HORIZON-HLTH-2027-01-DISEASE-08: Development of innovative antimicrobials against pathogens resistant to antimicrobials
  • Destination 3: HORIZON-HLTH-2027-01-DISEASE-10: Prevention and management of chronic non-communicable diseases in children and young people (GACD)
  • Destination 3: HORIZON-HLTH-2027-02-DISEASE-01-two-stage: Innovative healthcare interventions for non-communicable diseases
  • Destination 3: HORIZON-HLTH-2027-02-DISEASE-14-two-stage: Clinical trials for advancing innovative interventions for neurodegenerative
  • Destination 4: HORIZON-HLTH-2027-01-CARE-02: Personalised approaches to reduce risks from Adverse Drug Reactions due to administration of multiple medications
  • Destination 5: HORIZON-HLTH-2027-02-TOOL-01-two-stage: Development of predictive biomarkers of disease progression and treatment response by using AI methodologies for chronic non-communicable diseases
  • Destination 6: HORIZON-HLTH-2027-01-IND-01: Development of cell-free protein synthesis platforms for discovery and/or production of biologicals
  • Destination 6: HORIZON-HLTH-2027-02-IND-02-two-stage: Portable and versatile Point-of-care diagnostics
  • Destination 5: HORIZON-HLTH-2027-03-TOOL-08: Towards the next generation of frontier Artificial Intelligence models for healthcare
  • Destination 5: HORIZON-HLTH-2027-03-TOOL-04: Virtual Human Twins (VHTs) for integrated clinical decision support in prevention and diagnosis
  • Destination 5: HORIZON-HLTH-2027-03-TOOL-02: Advancing bio-printing of living cells for regenerative medicine

Type

  • Partner seeks Consortium/Coordinator

Organisation

AMIQALY

Consultancy

Prague, Czech Republic

Similar opportunities

  • Project cooperation

    Your exploitation partner and intellectual property and regulatory expert

    • Partner seeks Consortium/Coordinator
    • Destination 6: HORIZON-HLTH-2027-02-IND-02-two-stage: Portable and versatile Point-of-care diagnostics
    • Destination 5: HORIZON-HLTH-2027-03-TOOL-02: Advancing bio-printing of living cells for regenerative medicine
    • Destination 3: HORIZON-HLTH-2027-02-DISEASE-01-two-stage: Innovative healthcare interventions for non-communicable diseases
    • Destination 2: HORIZON-HLTH-2027-01-ENVHLTH-MISSCLIMA-03: Tools and technologies to support health adaptation to climate change
    • Destination 5: HORIZON-HLTH-2027-03-TOOL-08: Towards the next generation of frontier Artificial Intelligence models for healthcare
    • Destination 3: HORIZON-HLTH-2027-01-DISEASE-06: Development of monoclonal antibodies to prevent and treat infections from Flaviviruses
    • Destination 3: HORIZON-HLTH-2027-01-DISEASE-08: Development of innovative antimicrobials against pathogens resistant to antimicrobials
    • Destination 3: HORIZON-HLTH-2027-02-DISEASE-14-two-stage: Clinical trials for advancing innovative interventions for neurodegenerative
    • Destination 1: HORIZON-HLTH-2027-01-STAYHLTH-01: Addressing disabilities through the life course to support independent living and inclusion
    • Destination 5: HORIZON-HLTH-2027-03-TOOL-04: Virtual Human Twins (VHTs) for integrated clinical decision support in prevention and diagnosis
    • Destination 6: HORIZON-HLTH-2027-01-IND-01: Development of cell-free protein synthesis platforms for discovery and/or production of biologicals
    • Destination 3: HORIZON-HLTH-2027-01-DISEASE-05: Development of novel small molecule antiviral therapeutics for pathogens with epidemic potential
    • Destination 3: HORIZON-HLTH-2027-01-DISEASE-10: Prevention and management of chronic non-communicable diseases in children and young people (GACD)
    • Destination 4: HORIZON-HLTH-2027-01-CARE-02: Personalised approaches to reduce risks from Adverse Drug Reactions due to administration of multiple medications
    • Destination 2: HORIZON-HLTH-2027-01-ENVHLTH-02: Integrating climate-related exposures into the human exposome and characterising its changes in response to climate change
    • Destination 3: HORIZON-HLTH-2027-01-DISEASE-07: Development of monoclonal antibodies to prevent and treat infections from Filo-, Nairo-, Phenui-, Picorna- and Toga viruses
    • Destination 5: HORIZON-HLTH-2027-02-TOOL-01-two-stage: Development of predictive biomarkers of disease progression and treatment response by using AI methodologies for chronic non-communicable diseases

    Leonardo Casado Delgado

    IP Senior Consultant & Innovation Specialist at ClarkeModet

    Madrid, Spain

  • Project cooperation

    Horizon Europe Collaboration - HTA and regulatory affairs - Betthera s.r.o.

    • Partner seeks Consortium/Coordinator
    • Destination 6: HORIZON-HLTH-2027-02-IND-02-two-stage: Portable and versatile Point-of-care diagnostics
    • Destination 5: HORIZON-HLTH-2027-03-TOOL-02: Advancing bio-printing of living cells for regenerative medicine
    • Destination 3: HORIZON-HLTH-2027-02-DISEASE-01-two-stage: Innovative healthcare interventions for non-communicable diseases
    • Destination 2: HORIZON-HLTH-2027-01-ENVHLTH-MISSCLIMA-03: Tools and technologies to support health adaptation to climate change
    • Destination 5: HORIZON-HLTH-2027-03-TOOL-08: Towards the next generation of frontier Artificial Intelligence models for healthcare
    • Destination 3: HORIZON-HLTH-2027-01-DISEASE-06: Development of monoclonal antibodies to prevent and treat infections from Flaviviruses
    • Destination 3: HORIZON-HLTH-2027-01-DISEASE-08: Development of innovative antimicrobials against pathogens resistant to antimicrobials
    • Destination 3: HORIZON-HLTH-2027-02-DISEASE-14-two-stage: Clinical trials for advancing innovative interventions for neurodegenerative
    • Destination 1: HORIZON-HLTH-2027-01-STAYHLTH-01: Addressing disabilities through the life course to support independent living and inclusion
    • Destination 5: HORIZON-HLTH-2027-03-TOOL-04: Virtual Human Twins (VHTs) for integrated clinical decision support in prevention and diagnosis
    • Destination 6: HORIZON-HLTH-2027-01-IND-01: Development of cell-free protein synthesis platforms for discovery and/or production of biologicals
    • Destination 3: HORIZON-HLTH-2027-01-DISEASE-05: Development of novel small molecule antiviral therapeutics for pathogens with epidemic potential
    • Destination 3: HORIZON-HLTH-2027-01-DISEASE-10: Prevention and management of chronic non-communicable diseases in children and young people (GACD)
    • Destination 4: HORIZON-HLTH-2027-01-CARE-02: Personalised approaches to reduce risks from Adverse Drug Reactions due to administration of multiple medications
    • Destination 2: HORIZON-HLTH-2027-01-ENVHLTH-02: Integrating climate-related exposures into the human exposome and characterising its changes in response to climate change
    • Destination 3: HORIZON-HLTH-2027-01-DISEASE-07: Development of monoclonal antibodies to prevent and treat infections from Filo-, Nairo-, Phenui-, Picorna- and Toga viruses
    • Destination 5: HORIZON-HLTH-2027-02-TOOL-01-two-stage: Development of predictive biomarkers of disease progression and treatment response by using AI methodologies for chronic non-communicable diseases

    Pavel Kušnierik

    Regulatory Affairs Specialist and Client Partner at Betthera s.r.o.

    Hradec Králove, Czech Republic

  • Project cooperation

    We bring the manufacturers’ perspective to health research.

    • Partner seeks Consortium/Coordinator
    • Destination 6: HORIZON-HLTH-2027-02-IND-02-two-stage: Portable and versatile Point-of-care diagnostics
    • Destination 3: HORIZON-HLTH-2027-02-DISEASE-01-two-stage: Innovative healthcare interventions for non-communicable diseases
    • Destination 5: HORIZON-HLTH-2027-03-TOOL-08: Towards the next generation of frontier Artificial Intelligence models for healthcare
    • Destination 3: HORIZON-HLTH-2027-02-DISEASE-14-two-stage: Clinical trials for advancing innovative interventions for neurodegenerative
    • Destination 5: HORIZON-HLTH-2027-03-TOOL-04: Virtual Human Twins (VHTs) for integrated clinical decision support in prevention and diagnosis
    • Destination 5: HORIZON-HLTH-2027-02-TOOL-01-two-stage: Development of predictive biomarkers of disease progression and treatment response by using AI methodologies for chronic non-communicable diseases

    Stefano Brianza

    Owner at Biomech Innovations AG

    Nidau, Switzerland