Our Expertise - Your Benefit:

The eye.gnos consultants offer support in all aspects of immunology and ophthalmology - from clinical to research projects, from preclinical development to phase four studies, translational medicine from basic science to marketing. We offer document development and writing service - from investigator brochure to study protocols to regulatory documents. We can help with safety assessments, but also offer support for due diligences - for inlicensing and outlicensing projects and support financing rounds.
Strategy & Organization
  • Strategic consultation in the filed of Immunology and Ophthalmology drug development and commercialization

  • Development and Support of structural and strategic plans

  • KOL management

  • Advisory board organization and  -lead

 

Corporate Development
  • Onboarding and evaluation of candidates

  • Development and writing of business plans and product strategies

  • Inlicensing and outlicensing support

  • Corporate and marketing expansion strategy development and implementation - with a focus on the European market(s)

Clinical Development
  • Regulatory interactions with local / EU / US health authorities

  • ​Study design development including endpoints, sample size calculation,

  • Set-up. implementing and leading global clinical trials from Phase 1 to phase 3,

  • Global expertise in Ophthalmology and Autoimmunity and Inflammatory Disease indications

  • CRO selection and CRO management

Preclinical Development
  • Evaluation of targets and reserach strategy in Immunology and Ophthalmology

  • ​Preclinical drug development support

  • Evaluation of pathways and mechanisms

BD&L
  • Development of business strategy

  • Due diligence including evaluation of early targets, late preclinical and clinical candidates

  • Risk assessment, probability of success evaluation for inlicensing

  • Support of academic and pharma outlicensing projects including imaging and medical device

Imaging & Function
  • Expertise in multimodal retina imaging

  • ​Optical Coherence Tomography (OCT)

  • Fluorescein Angiography (FA)

  • Microperimentry

  • BCVA

  • Reading tests

Marketing
  • Marketing and brand strategy development and evaluation, with a focus on European markets

  • SWOT analysis for new entrants in the Immunology or Ophthalmology market

  • Relaunch and repositioning of established products

  • Launch support in new markets

Medical Affairs
  • KOL management, supported by a global KOL network established by the eye.gnos consultants

  • Development, design and delivery of meeting presentations

  • Phase 4 post marketing study design,  development and conduct

Document Development
  • Development and writing of all documents for all aspects of the pharma value chain

  • IB, study synopsis, protocols, HEOR value dossiers, study reports (CSR), scientific paper, regulatory documents, briefing books, labels, SOP's, marketing brochures, presentations, trainings etc...

  • English / German translations of all documents