The two new divisions, Pearl ReGXP and Pearl IDEAS, will provide registration, approval support and feasibility assessment services that complement the firm’s existing clinical research review offering.
Diana Caldwell, CEO of parent company Pearl Pathways, said: “We listened to the needs of existing and potential clients, and developed a family of businesses to support the regulatory and product development challenges facing bio-pharma and device companies of all sizes.”
Caldwell said smaller developers want this type of dedicated services, citing comments from Agile Therapeutics regulatory affairs president Grace Deebo as an example of such demand.
“For a smaller company such as ours, working with one company rather that three or four allows us to save time and trouble" Deebo said.
Pearl said the new divisions will create 20 new high level jobs in compliance, regulatory strategy and manufacturing quality over the next two years.
News of the new divisions follows just a few months after Pearl partnered with Canadian counterpart Trafalgar Ethics Board in an agreement designed to establish a cross boarder clinical monitoring organisation.