Janus Pharmaceutical Consulting Services

Our philosophy is that successful drug development starts with keeping the goal in mind, getting it right the first time, and controlling costs and timelines. Close attention to science and data allow us to be flexible where required.   


We provide strategic and hands-on input to the areas below and also offer support for in-licensing activities, development strategy mapping and experiment design and placement.    


We welcome an opportunity to start a conversation about your specific needs.    

Discovery/Medicinal Chemistry

  • Medicinal chemistry and organic synthesis support
  • Structure based drug design
  • Hit to Lead
  • Lead Optimization and candidate selection
  • Coordination of outsourced pre-IND activities

CMC/Manufacturing

  

  • Gap Analysis
  • CMC Strategy for Pre-IND through commercial
  • ID and qualification of CDMOs and vendors
  • Vendor management
  • CMC Problem solving 

Clinical/Regulatory

  • Regulatory filing preparation
  • FDA meetings
  • Clinical Operations Support
  • Protocol and IB preparation 
  • Orphan Drug Applications
  • Clinical Study Reports
  • Statistical Support (with EvidenceTx). 

Opportunity Assessment

  • Prioritizing R and D pipelines
  • Opportunity Review
  • Market opportunity check on existing programs
  • Patent analysis
  • In licensing opportunities

Project Leadership

  • Identify lead molecules and programs
  • Get your molecule from Lead Optimization to Phase 1
  • Development problem solving
  • Preparation of scientific papers and posters

Virtual Company Mentoring

  • Advice and guidance on managing a virtual company
  • Identification of key skilled consultants
  • Identification of academic research labs as collaborators
  • Building a virtual research network to support MOA and LO activities

Janus Pharmaceutical Consulting LLC, Saratoga, CA 95070