Therapeutic & Medical Device Product Development & Testing

Our team has demonstrated preclinical & clinical expertise in oncology, pediatric disorders, immune and autoimmune diseases, behavioral health, neuroradiology & surgery.

Original research findings have been published in some of the highest-impact scientific journals including Nature, Nature Cell Biology, Cancer Research, and PNAS.

We can support your preclinical & clinical study needs in multiple ways:

  • Developing IND, NDA & 505(b)2 enabling therapeutic studies and 510k & De novo enabling medical device studies
  • Consultations on clinical protocols
  • Drafting/editing manuscripts, grants, contracts, slide decks & regulatory documents (eCTD modules 2 & 4)
  • Expert recruitment: referrals of academic, industry & CRO partners
  • Funding: sourcing non-dilutive & dilutive capital including out-of-the-box, non-traditional mechanisms