rtharin@cerneos.com

Projects

We develop and implement regulatory strategies, manage projects and prepare submissions for biologic, medical device and drug submissions.  Our integrated approach has been successfully used by large and small firms to launch products in the US and overseas. Cerneos is working with drug, biotech and device firms in oncology, cardiology, infectious diseases and personalized medicine.

A partial list of the exciting active projects we are working on: 

  • 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 COVID Therapeutic
  • Telemedicine solutions for home exams
  • Reviewing product labeling & marketing materials for drug products

STEM support Programs

Cerneos is committed to supporting global Science, Technology, Engineering and Mathematics (STEM) programs in its global operations.  We support efforts to promote STEM career development and entrepreneurship.

  • Advisory Board membership and mentorship programs for incubators
  • Beyond the PhD. Mentoring and resource programs for Post-Doctoral Fellows
  • Business development and industry connections for STEM entrepreneurs

For more information on STEM initiatives contact our CEO – Richard Tharin at rtharin@cerneos.com