Independent softgel capsule expertise for your project
From initial concept to final product, we bring transparency and expertise to navigate the complexities of your softgel capsule project.
How we can help
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
Avoid issues of limited transparency and knowledge when coming up with your product. With a strong background in leading softgel CDMOs, we bring transparency to your project and ensure complete development documentation.
Mitigate development risks
Avoid risks in the development process. From the beginning of the project. to the end, we consider critical aspects for the entire capsule from day one following our structured, risk-based approach tailored for soft gel capsules.
Case study: Lifecycle management of a soft capsule
The client
An international leader in kidney and blood health
The task
Provide independent expertise to assess the decision on the development of a BCS class IV NCE in a liquid-filled hard capsule as a line extension to a soft capsule.
Outcome
We first performed a thorough review of the development documentation of the softgel capsule and preliminary hard capsule prototypes. As the bioavailability of the formulation was regarded as critical, strong focus was placed on the dissolution performance and bioavailability of the two formulations.
A regulatory analysis provided possible scenarios for the switch in Europe.
Lastly, we also performed a benchmarking cost of goods (COGs) calculation.
Thus, in consideration of technical feasibility, bioavailability, regulatory and commercial aspects, we were able to provide the basis for management´s decision on the program.