White Paper

Guided By Vision: Redefining OSD Development Through Foresight And Innovation

GettyImages-1465073074 tablets, OSD, pills

Successfully advancing an oral solid dose (OSD) program demands more than technical execution — it requires strategic alignment around four foundational pillars: technology and scientific expertise, a strong global network, tailored service models, and regulatory excellence. Together, these pillars create a resilient framework for navigating the scientific, operational, and compliance complexities inherent in oral drug development. From early formulation challenges to scale-up and commercial readiness, proactive planning and integrated capabilities help teams anticipate risks, accelerate decision-making, and maintain momentum across development stages.

By incorporating predictive in silico modeling and advanced formulation technologies, development teams can identify potential bioavailability, stability, and manufacturability issues early, reducing costly rework later. Leveraging a global CDMO network that spans formulation development, process optimization, clinical supply, and commercial manufacturing ensures scalability, regional compliance, and consistent quality standards worldwide. At the same time, customized service models allow programs to adapt to molecule-specific requirements and evolving regulatory expectations. Anchored by proactive quality systems and regulatory strategies, this integrated approach minimizes risk, supports smoother approvals, and enables reliable market access — positioning sponsors to deliver innovative oral therapies efficiently and with confidence.

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