In-Licensing/R&D

Alpha-Pharma offers in-licensing development of generic pharmaceuticals in our R&D Center as well as outsourcing of full size commercial batch production.

We are able to assist our partners with assignments such as :

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

In addition our regulatory affairs team is able to compile technical data as per country specific dossiers and may assist in carrying out bioequivalence studies through relevant clinical research organizations as per required guidelines. Further, we have the capability of manufacturing final dosage forms in country specific cGMP approved facilities.