In-Licensing/R&D

Alpha-Pharma offers in-licensing for the development of generic pharmaceuticals in our R&D Center and provides outsourcing services for full-size commercial batch production.

We can assist our partners with various assignments, including:

• Analytical method development and validation
• Process validation
• Fixed dose formulation development
• Assay & dissolution testing
• Lab scale trial batch production
• Dossier development
• Contract manufacturing on a commercial basis

In addition, our regulatory affairs team can compile technical data for country-specific dossiers and may assist in conducting bioequivalence studies through relevant clinical research organizations, following required guidelines. Furthermore, we have the capability to manufacture final dosage forms in country-specific cGMP-approved facilities.