As niche dosage forms, soft gelatin capsules require extensive expertise for successful development. Partnering with the right contract development and manufacturing organisation (CDMO) is essential to avoid inefficiencies, increased development costs, and protracted timelines.

The CDMO selection process for softgel capsules

 The selection process typically entails the following:

1. Definition of a target product / development profile

2. Pre-screening of possible CDMO partners and selection of 3-5 suitable candidates

3. RfP process

4. Systematic evaluation of proposals, ideally f2f meeting with shortlisted candidates

5. Decision and establishment of contractual framework

While cost and timeline are objective, high-importance factors, some "soft" factors are often overlooked, and can critically influence project success. In this article we outline these essential considerations.