Services
Based on the innovative PDG technology, Atacama Labs offers pharmaceutical development and manufacturing services. The services are delivered together with a Contract Manufacturing Organization located in Nuremberg, Germany. The services are available for development of products based on both generic APIs and new chemical entities.
Customers can easily deploy the PDG Technology
TM by following a straight-forward product development process. The process contains three steps.
Step 1 - Feasibility granulation
Atacama Labs develops a preliminary formulation and granulates feasibility batches for an attractive fixed fee (omitted in case of full scale development). The granules can be tableted either by Atacama Labs or by the customer. The customer can analyze the tablets and, based on the results, make a feasibilty assessment.
Step 2 - Full-scale galenic developmentAtacama Labs develops a formulation and tablets based on customer's detailed specifications. Atacama also provides clinical trial supplies. The development and manufacturing takes place in GMP and GLP compliant facilities. In development, Atacama Labs collaborates with R5 Pharmaceuticals, located in Nottingham, UK.
Step 3 - ManufacturingThe Contract Manufacturing Organization produces the granules using the PDG-0260 equipment. Depending on the customer requirements, product can be provided as granules, tablets (bulk), blistered tablets or fully packaged products for specified countries.