PROJECTS

Cerneos Group develops and implements regulatory strategies, manages projects and prepares submissions for biologics, medical devices and drugs.

  • IND, ANDA and BLA

    submissions for small molecule and biologic products

  • CMC preparation

    for BLA and NDA projects

  • Microfluidic assay development

    for remote blood testing

  • Regulatory submissions

    management with FDA

  • Briefing Book development

    for Type A, B, C meetings with FDA

  • Fundraising and Grant Proposal Development

    for early stage biotech, medical software and medical device ventures

  • Grant proposals

    for vaccine therapeutic

  • Telemedicine solutions

    for home exams

  • Reviewing product labeling

    and marketing materials for drug products