Galenical & Analytical Development

Bluepharma holds dedicated, certified and well equipped facilities for the development of pharmaceutical products. In direct connection with the industrial facility, the R&D laboratory offers services ranging from the design of new technologies for drug delivery to the complete formulation and analytical development up to the manufacturing of pilot scale batches.

Pre-formulation studies | Formulation development
The Formulation Team has dedicated and well equipped laboratories, which enable the development of new pharmaceutical formulations to meet the current demands of an ever growing patent protected market. Bluepharma has currently the capability for the development of potent drugs, from the initial steps of the development until the manufacturing of submission batches.
Development and Validation of Analytical methods
The experienced R&D team is also responsible for the development and validation of efficient and sensitive analytical methods, in close contact with the Quality Control laboratories, enabling an integrated and cost efficient approach.

Pilot batch production (feasability and validation of manufacturing process) | Scale-Up studies
We offer the integration of development laboratories with industrial manufacturing facilities and assure that successful laboratory scale products will be able to coup with industrial production processes, reducing time to market in a cost effective way. The availability of qualified manufacturing equipments allow also the production of small scale batches targeting niche areas, including products containing potent drugs.
Stability studies according to ICH recommendations
We are equipped with dedicated facilities to perform full stability studies, according to the latest ICH and FDA recommendations, and following the requirements for the Climatic Zones I, II, III and IV.

Manufacture and packaging of Human Investigational Medicinal Products
Following its strong connection to the academic and innovative research, we are also certified for the manufacturing and packaging of Human Investigational Medicinal Products.