ProPharma Advances Technology Enablement Strategy with AI-Assisted Capability for ANDA Submission Development

New proprietary capability enhances ProPharma's regulatory service delivery model, helping clients accelerate submission development while maintaining the highest standards of quality and compliance.

RALEIGH, N.C., July 8, 2026 /PRNewswire/ -- ProPharma, the leading global provider of regulatory, clinical, and compliance services for the life sciences industry and a portfolio company of Odyssey Investment Partners, today announced another milestone in its Technology Enablement Strategy with the deployment of a proprietary AI-assisted capability that enhances how the company develops Abbreviated New Drug Application (ANDA) submissions for clients.

The AI-assisted capability was purpose-built to support ProPharma's regulatory teams and their clients in the development of ANDA submissions. By intelligently aggregating and analyzing information from multiple data sources and document formats, the technology generates structured first drafts that significantly reduce manual authoring effort. This enables ProPharma's regulatory experts to dedicate more time to scientific evaluation, strategic regulatory guidance, quality review, and client collaboration.

"The future of regulatory submissions is not about replacing experts with technology," said Matthew Weinberg, President, Regulatory Sciences at ProPharma. "It's about empowering experts with better tools. By combining human expertise with AI-enabled efficiencies, we are helping clients reduce authoring timelines, improve operational effectiveness, and maintain the scientific rigor and regulatory excellence that have always been central to ProPharma's approach in a more cost-effective way."

Developed specifically to enhance ProPharma's internal regulatory delivery process, the capability is designed to improve consistency, completeness, and traceability throughout submission development while supporting the rigorous quality and compliance standards expected by global health authorities. It also enables more efficient management of regulatory questions and deficiency responses throughout the submission lifecycle.

For clients, these enhancements translate into meaningful benefits, including:

• Accelerated ANDA preparation and submission timelines
• Reduced manual document authoring effort
• Improved consistency and completeness across submission content
• Enhanced traceability throughout submission development
• More efficient management of regulatory questions and deficiency responses
• Better utilization of regulatory resources while maintaining high-quality submissions

"Technology should enhance expertise, not replace it," said Dawn Sherman, Chief Executive Officer of ProPharma. "Our Technology Enablement Strategy reflects our commitment to continuously improving how we serve clients by equipping our experts with innovative capabilities that increase efficiency, strengthen quality, and accelerate delivery. This AI-assisted capability is one example of how we're investing in the future of expert-led life sciences services."

Technology Enablement is ProPharma's enterprise-wide strategy for integrating proprietary technology, intelligent automation, and artificial intelligence into the way its experts deliver services across the organization. ProPharma is embedding purpose-built technologies into its expert-led delivery model across regulatory affairs, clinical research, pharmacovigilance, quality and compliance, medical information, and consulting services. The initiative is designed to improve efficiency, consistency, scalability, and client outcomes while preserving the scientific expertise, regulatory judgment, and human oversight that remain at the core of every engagement.

About ProPharma
For more than 25 years, ProPharma has improved patients' health and wellness by providing expert guidance that empowers biotech, pharmaceutical, and medical device organizations to confidently advance scientific breakthroughs and bring new therapies to market. With deep expertise in regulatory sciences, CRO services, quality and compliance, pharmacovigilance, medical information, FSP solutions, and digital transformation, ProPharma delivers integrated, end-to-end solutions that help organizations navigate complexity, mitigate risk, and accelerate the development and commercialization of life-changing therapies. For more information about ProPharma, please visit propharmagroup.com.

About Odyssey Investment Partners
Odyssey Investment Partners is a leading private equity investment firm with more than a 25-year history of partnering with skilled managers to transform middle-market companies into more efficient and diversified businesses with strong growth profiles. Odyssey makes majority-controlled investments in industries with a long-term positive outlook and favorable secular trends. For further information about Odyssey, please visit odysseyinvestment.com.

SOURCE ProPharma Group Holdings LLC