Target Product Profile, Regulatory Partnering Strategies Are Essential For Sustainable Product Success

Developing a robust and attainable target product profile (TPP) is critical to determine a product’s eventual commercial formulation, and it is also a key step in protecting pharmaceutical intellectual property (IP). Doing so requires a regulatory strategy to align your proposed pharmaceutical development plan with business objectives.

For drug developers, forming a regulatory strategy is something best left to experts and this is usually delegated to CDMO partners. A growing number of CDMOs are now recognizing that comprehensive regulatory strategy is the secret ingredient of any successful project. Partnering with a CDMO that offers strategy, submission, authoring, publication of submission, lifecycle management, and market expansion support helps drug sponsors of all shapes and sizes to achieve their objectives detailed in their TPP.

Learn more about the best practices to keep your product’s commercial objectives front of mind, weighing them against the drug’s pharmacology and clinical development necessities to describe an optimized but market-realistic view of your goals and how the right partner can successfully guide your product through the process.