Choosing the right form for your oral controlled release (OCR) product is critical. The wrong approach to development and manufacturing can add unexpected costs and delays. Learn how a CDMO partner experienced in working with solid OCR formulations can help to ensure success in product development.
Pharma companies aiming to tech transfer or scale up modified release formulations to take into clinical studies often encounter hurdles when the formulation is not robust. Review how to select the right polymers (and other best practices) and ensure you have a robust multiparticulate capsule formulation strategy.
What if you could limit and position a formulation change as only a CMC prior approval supplement under the FDA’s scale-up and post-approval changes guidance? A client in this position accomplished a complex reformulation and successful CMC supplement filing in less than a year.
Societal™ CDMO is a bi-coastal CDMO with capabilities spanning pre-IND development to commercial manufacturing and packaging for a wide range of therapeutic dosage forms with a primary focus in small molecules.
Finding a strategic CDMO partner that will offer tailored solutions for your late-phase clinical and commercial needs, mitigate risk as you bring your drug product to market, and help bolster your future supply chain is crucial for meeting project milestones on time and avoiding unexpected costs.
