with specialized expertise in one or more of the prioritized workstreams are encouraged to be considered. Former FDA experience is not required.... at a pharmaceutical manufacturing operation in Central California. The engagement involves a pharmaceutical drug product incorporating...
, and applicable food safety controls. The consultant will conduct an FDA-focused regulatory gap assessment to evaluate existing.... The initial engagement will focus on assessment and preparation rather than a comprehensive mock FDA inspection. Key...
and Reporting Activities Travel: Travel to the manufacturing facility in Southern Spain required Position Overview... sciences manufacturing facility in Spain. The facility manufactures an investigational tissue-engineered Advanced Therapy...
/ Parenteral Technical Development Expert to provide hands-on technical support for the development of a sterile liquid drug... product. The consultant will support formulation and finished-product development, process development and scale-up...
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...
quality systems, and identify compliance gaps against applicable U.S. FDA and EU GMP requirements. The audits will encompass...GMP CDMO Auditor – AAV Gene Therapy / FDA & EU GMP / Pivotal Readiness Location: Columbus, OH and Massachusetts Work...
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...
submission is positioned for FDA filing readiness. The consultant will also support Pre-NDA meeting strategy and provide... to help position the application for FDA filing readiness and planned submission by the end of 2027....