Quality Management and Regulatory Affairs
DLH strives to attain the shortest path to product approval that ensures quality and regulatory compliance. Quality is managed by implementing and deploying continuous improvement processes, and tools such as Lean Six Sigma. Expertise in documentation management, supplier/vendor management, protocol compliance, and protocol submission management leads to an emphasis on quality control at every step. Training programs for study personnel, participants, and vendors, as well as frequent audits, allow for continual improvement.
We develop and write regulatory documents and offer cloud-based eTMF and eSubmission platforms. Protocol amendments, safety events and reports, FDA RFI responses, briefing documents, IND submissions, and 510K applications are among the many documents DLH researchers draft and submit to satisfy regulatory requirements.