Website: https://www.k2-biolabs.com/

Description: K2bio offers CRO and consultation support built on decades of experience in product research and development (R&D); quality assurance (QA); and chemistry, manufacturing, and controls (CMC), including achieving FDA approval for all levels of clinical trials and into commercialization. We help to ensure that required attributes are captured early to help reduce time, cost, and frustration in advancing candidates through the drug/biologic product lifecycle. Our integration of science and phase-appropriate compliance enable us to shepherd each product in development from concept to market.

Services tailored to client needs and goals include

  • Good Laboratory Practice (GLP) and non-GLP in vitro and in vivo support
  • Analytical development
  • R&D support
  • CMC and QA
  • Scale-up for product commercialization