Description.
At its core, technical writing involves the translation of overly complex information into accessible formats, including everything from drug development reports and clinical trial documentation to product manuals and regulatory submissions. Our technical writers ensure that each document adheres to guidelines and regulations set forth by regulatory bodies. When precision and clarity are paramount, technical[…..] […]
Our flexibility and project experiences range from the qualification of an individual piece of equipment to an entire facility. Our PharmEng professionals have extensive experience in the development, implementation and execution of: Enhanced Detail Design Reviews – Design Qualification (DQ) User Requirements Specifications (URS) Functional Specifications (FS) Risk Management Tools Commissioning / Qualification / Validation[…..] […]
Process Validation PharmEng professionals possess experience in validating pharmaceutical and biopharmaceutical manufacturing processes. Our team of experts will prepare necessary protocols incorporating all critical parameters of the process. Execution will incorporate data analysis and resolve any non-conformances. PharmEng will collect and evaluate data to ensure that a process is capable of consistently operating according to[…..] […]
PharmEng engineers are experienced in building scalable and robust pharmaceutical production facilities and processes while employing state of the art techniques to meet and exceed operational and regulatory requirements. Our experts have successfully completed facility and process engineering projects including; vaccine manufacturing, sterile manufacturing, oral solid and liquid dosage manufacturing, API manufacturing, medical device manufacturing,[…..] […]
