Ricerca will provide preclinical services, while Fulcrum will support regulatory activities.
CRO Ricerca Biosciences and Fulcrum Pharma, a provider of drug development consulting and regulatory services, are combining resources. The collaboration is expected to create a streamlined and efficient process to move a candidate from development to clinical evaluation.
“Fulcrum Pharma brings deep experience in IND authorship and regulatory approval, which fits well with Ricerca’s preclinical services in discovery pharmacology, chemical development, and drug safety assessment,” notes Ian Lennox, CEO of Ricerca. “The relationship greatly expands our ability to serve our clients who are preparing for regulatory submission anywhere in the world.”
Ricerca Biosciences provides the full range of preclinical services from early discovery medicinal chemistry, compound screening, profiling, and lead optimization through full drug safety, metabolism, and efficacy development support, as well as clinical supply and commercial API production capability. Fulcrum Pharma provides strategic and operational regulatory support to assist clients in the authorship and approval of regulatory submissions.
“The collaboration offers our early-stage clients a streamlined service to move efficiently through preclinical development to creation of high-quality IND submissions,” remarks Patrick K. Donnelly, chairman and CEO of Aptiv Solutions, Fulcrum’s parent company. “This approach, coupled with our expertise in adaptive clinical trial design, will provide our clients with the ability to accelerate the development of their products and stay ahead of the competition.”
