OSD
Complex generic OSD development brings together formulation challenges, bioequivalence risk and regulatory complexity. Addressing these areas together is important for reducing development risk and building a stronger path towards filing.
In this case study, we share how we supported our client with a complex, poorly soluble generic product with high pharmacokinetic variability and a complex regulatory pathway. By combining early regulatory alignment, QbD-led formulation development, discriminatory dissolution and a fit-for-purpose bioequivalence strategy, the product progressed successfully through development and filing towards commercialisation.
What you can take from the case study
- See how early regulatory alignment reduced the risk of late-stage strategic changes
- Explore how QbD-led development and discriminatory dissolution supported formulation and process understanding
- See how a reference-scaled bioequivalence strategy addressed high pharmacokinetic variability
- Explore how connected expertise helped reduce development risk and strengthen filing readiness
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