Micro-Sphere S.A. is a (CDMO) with specialist expertise in the spray drying of APIs and HPAPIs as well as capsule filling with a deep focus on inhalation products.

Founded in 1998, we have a long track record in overcoming complex formulation challenges and taking products from development batches to commercial phase,

From our state-of-the-art facility in Monteggio Switzerland, our 50-strong team deliver both clinical and commercial scale spray drying and capsule filling services.

Our quality assurance team guarantees full cGMP compliance with all regulatory requirements and standards.

Our quality systems are approved and regularly inspected by EU GMP, US FDA, Swissmedic and Japanese authorities and Micro-Sphere is registered by the FDA as a FDF (Finished Dosage Facility).

We also offer regulatory support to customers, providing all the documentation required for submissions.

Our Quality Control laboratory is equipped with state-of-the-art instruments.

Our core analytical services include:

• Development, optimization, validation, and transfer of analytical methods
• Segregated inhalation drug testing area, including (aPSD), and (DUSA)
• Stability studies (ICH)

To every new project Micro-Sphere assigns a dedicated project team with expertise across every aspect of the project.

Micro-Sphere R&D department offers state-of-art technologies and targeted solutions to specific customer needs.