Projects

DES Biologics Consulting LLC has been retained by several clients in the biotech/pharma and financial investment communities for the following project areas:

  • Evaluate novel biologics development programs for virtual and small companies
  • Carry out due diligence on biologics for potential acquisition/licensing
  • Develop  technical transfer strategy of new biologics to potential third party manufacturers of drug substance and drug product
  • Review CMC Regulatory documents e.g., INDs/CTAs/BLAs/MAAs
  • Conduct webinars and individual consultation on development of biosimilars and current trends
  • Perform organizational reviews for the pharmaceutical development and manufacturing groups of clients to help them develop their long-term business and technical strategies
  • Provide expert consultation to major financial investment firms to advise clients on new directions in specific biopharmaceutical product development.
  • Serve as subject matter expert for patent litigation and other legal matters concerning biologics development and manufacturing.