Quality System Design:
Coderant can build a Quality Program customized to individual corporate and regulatory goals. This includes all aspects of developing a quality program from establishing a macro corporate quality program to creating individual functional quality specifications.

GXP Audits
Coderant’s Quality Managers are continually trained with current GXP’s and are routinely engaged to conduct both internal audits for Coderant clients as well as audits for their contracted labs and manufacturers. Specific department audits are also accomplished including the following functional areas: Vendor Audits, QA Audits, QC Audits, Production Dept. Audits, Engineering Dept. Audits, R&D Audits, CMO Audits and CRO Audits.

Writing Standard Operating Procedures and Policies
Coderant is staffed with fully qualified technical writers and regulatory specialists to research, draft and publish Standard Operating Procedures (SOPs) and Quality Program Procedures across a broad spectrum of functional areas, including process development, clinical development and manufacturing.