Parexel International, one of the world’s leading contract research organizations (CROs), has entered into a strategic collaboration with U.S.-based Weave Bio to accelerate regulatory submissions using artificial intelligence. Under the agreement, Parexel will act as Weave Bio’s design partner, contributing its deep expertise across regulatory consulting areas including clinical, non-clinical, pharmacology, and chemistry, manufacturing, and controls (CMC). The partnership will focus on strengthening Weave Bio’s AI-native platform to streamline the complex regulatory process involved in drug approvals.
By combining Parexel’s established global regulatory capabilities with Weave Bio’s AI-powered automation, the collaboration aims to cut down submission timelines, reduce costs, and ensure smoother compliance pathways for pharmaceutical companies. This will ultimately help bring innovative therapies to patients faster. Parexel will also hold exclusivity as the sole CRO licensed to implement Weave Bio’s solutions after product launches, a move expected to reinforce its leadership position in regulatory consulting.
The two companies will showcase their joint efforts at the upcoming Regulatory Affairs Professionals Society (RAPS) Convergence event in Pittsburgh, where they plan to highlight how AI can transform regulatory workflows. Industry experts see this partnership as a strong step towards modernizing the approval landscape and making the path to market for life-saving therapies more efficient and reliable.