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Streamline the development process
We bring specialized know-how on excipients, formulations, process development and regulatory aspects. Drawing on a portfolio of over 50 softgel projects, we make the development activities more efficient.
Bridge the knowledge gap
As softgel development and manufacture are often outsourced, product owners have often limited transparency and know-how. With a strong background at leading softgel CDMOs, we bring transparency to your project and ensure complete development documentation.
Mitigate development risks / something else?
As softgel development and manufacture are often outsourced, product owners have often limited transparency and know-how. With a strong background at leading softgel CDMOs, we bring transparency to your project and ensure complete development documentation.
Project example: development of an extended-release tablet
The Client: A pharmaceutical company developing an NCE drug for world-wide rollout
The Challenge: Develop a formulation for a poorly soluble compound matching a specific extended-release profile.
Our Solution: Applying DoE principles, we proposed the first screening program which led to definition of the formulation. Drawing on deep understanding of the excipient palette for extended-release formulations, we planned the subsequent series of trials and finetuned the prototype to match the target dissolution characteristics.
In parallel we supported the dissolution method development and planning of clinical supplies, including drafting and review of the IND file.
The final market formulation was defined based on the development work we supported.