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Wheeler Bio and Pharmefex Consulting Announce Strategic Partnership to Integrate IND Drafting and CMC Support into Wheeler's ModularCMC™ Platform
Wheeler Bio, Inc., a U.S.-based contract development and biomanufacturing organization (CDMO), today announced 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.
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[{"type":"text","content":"OKLAHOMA CITY, Sept. 9, 2025 /PRNewswire/ -- Wheeler Bio, Inc., a U.S.-based contract development and biomanufacturing organization (CDMO), today announced 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.","length":434,"tagName":"p"},{"type":"image","alt":"Wheeler Bio, Inc.","displaySize":"","headline":null,"caption":"Wheeler Bio, Inc.","className":"","disableSlideshowImg":false,"size":{"original":{"width":400,"height":116,"url":"https://media.zenfs.com/en/prnewswire.com/647765c3f3722643c33f2b284dfb6712"},"resized":{"url":"https://s.yimg.com/ny/api/res/1.2/nx5fA2MgPEupsRL4_WHMhQ--/YXBwaWQ9aGlnaGxhbmRlcjt3PTcwNTtoPTIwNDtjZj13ZWJw/https://media.zenfs.com/en/prnewswire.com/647765c3f3722643c33f2b284dfb6712","width":400,"height":116}},"href":"https://mma.prnewswire.com/media/2769017/Wheeler_Bio__Logo.html","hrefExternal":true,"rel":"nofollow"},{"type":"text","content":"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.","length":550,"tagName":"p"},{"type":"text","content":"As a High-Science/High-Touch biologics CDMO, the Wheeler Bio scientific team is deeply talented with aggregate industry experience that includes working on over 1,400 unique molecules. 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.","length":463,"tagName":"p"},{"type":"text","content":""Biopharmaceutical innovators are seeking platform approaches that enable rapid progression of their innovative molecules," said...
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