Product Development Services (PDS)

NextPharma PDS operates globally with six centers of excellence in Europe and North America. PDS services include preformulation studies, formulation development, design, development and optimization of lyophilisation cycle, manufacturing for clinical trial materials, analytical and microbiological testing, clinical trial labeling and kitting and stability testing according to ICH guidelines as well as regulatory support and product dossier development and registration.

Our expanded sterile businesses now includes sterile product development and manufacturing capabilities in San Diego, California where we are able to support non-clinical through clinical development of sterile products including biologics and cytotoxics. In addition, our San Diego facility is ISO 13485:2003 certified for medical devices and manufactures medical devices with batch sizes spanning the needs of research and development through to commercial quantities of product.

Our world class PDS team gives you the confidence and knowledge that your products will be produced to meet your requirements. Customer satisfaction is a key importance to NextPharma: each customer receives a dedicated project manager responsible for managing the development project within NextPharma and ensuring the highest level of customer service. As product transition from development to commercial scale, we are able to provide a seamless process from non clinical product formulation to commercial scale manufacturing, either within NextPharma, or if the customer wishes to a site of his chosing.