execution Duration: Three-day facility audit, with report preparation following the audit Start: Before the end... Consultant to conduct a comprehensive three-day onsite audit of a life sciences testing facility in Northern California. The...
to medical device studies, including ISO 14155 and relevant U.S. FDA regulations. The anticipated engagement includes... to conduct a routine Good Clinical Practice audit in New York City during the fourth quarter of 2026. The consultant...
program. Advise on U.S. FDA regulatory strategy and development planning from the current clinical stage through later-stage... advancing a therapeutic program for amyotrophic lateral sclerosis (ALS). The consultant will provide strategic and hands...
therapy drug substance (DS) and drug product (DP) manufacturing operations. The consultant will evaluate manufacturing... practices, documentation, controls, and supporting records within the agreed audit scope. Apply gene therapy manufacturing...
framework. The engagement will initially focus on a comprehensive compliance gap assessment, including evaluation of current... and labeling compliance processes, and integration of compliance activities into the existing Quality System. The consultant...
organization developing a new formulation of an FDA-approved biologic. The program has completed multiple nonclinical studies..., and the existing regulatory package has been discussed with FDA and is currently under agency review. The immediate...
development program preparing for FDA engagement and a pre-IND submission. The consultant will provide specialized FDA... experts may be incorporated separately as needed. Key Responsibilities Serve as the lead FDA regulatory consultant for the...
organization in Indiana. The consultants will provide hands-on support addressing a significant backlog of open and overdue... manufacturing investigations. The primary objective is to accelerate investigation completion and closure while ensuring...
-term Phase I clinical trial activities while establishing the foundation for broader CRO capabilities. The immediate..., and accelerate the development and implementation of SOPs, quality processes, and supporting infrastructure required for trial...
Medical Device Quality Systems & FDA Inspection Readiness Consultant Location: Atlanta/Duluth, Georgia area Work... Overview We are seeking an experienced Medical Device Quality Systems Consultant to provide hands-on support for the startup...