Wheeler Bio, Inc., a US-based contract development and biomanufacturing organisation (CDMO), has announced that it has established a strategic partnership with Pharmefex Consulting, an expert CMC consultancy with deep expertise in regulatory strategy and technical operations, focused on accelerating client success in Investigational New Drug (IND) filings and regulatory submissions.

This collaboration further enhances Wheeler's ModularCMC platform by integrating the preparation of high-quality Common Technical Document (CTD) Module 3 documentation in support of IND submissions for programs advancing from discovery to IND-enabled First-in-Human clinical trials. Adding Pharmefex's proven biologics regulatory expertise to Wheeler's streamlined and agile manufacturing platform supports biopharmaceutical innovators by providing a comprehensive CMC offering, including a sound and defensible regulatory strategy.

Wheeler's ModularCMC platform is designed to streamline the path from discovery to clinical study initiation, with maximum speed, agility and scalability while offering a High-Touch approach based on timely transparency, scientific rigor, and a true partnering mindset.

Patrick Lucy, President and CEO of Wheeler Bio said, “Biopharmaceutical innovators are seeking platform approaches that enable rapid progression of their innovative molecules. Adding Pharmefex's deep regulatory capabilities to our ModularCMC platform lives up to that mandate.”

Pharmefex Consulting brings decades of combined experience across CMC strategy, regulatory submissions, and technical operations for biologics, biosimilars, and advanced therapies. They will collaborate closely with Wheeler Bio's scientific, manufacturing and quality teams to streamline the preparation and review of IND-enabling documentation including risk assessments, analytical methods, and process development reports.