Gilero offers pharmaceutical and medical device development. With a focus on design for manufacturability, we utilize our in-house process development lab to design and build the appropriate process that is able to be validated. We develop the right process for each product rather than forcing the product design into a particular process. We also write and execute process validations, including installation, operational, and performance qualifications (IQ/OQ/PQ).
Our experience in building and proving out manufacturing processes ensures a smooth transfer to production. We integrate a high level of accountability in this phase to make certain that the product design can be manufactured to meet the product requirements. Once process equipment is transferred, Gilero is on-site to train operators, and support the validation of the process. Once production begins, we work closely with our customers to design automated systems that assist in the production ramp.
