in-house. Serving clients in 18 Countries Successful NDA and ANDA drug registrations In good standing with theFDA, PMDA... pharmaceutical manufacturing professional who is ready to take on greater leadership responsibility and play a key role in the...
in-house. Serving clients in 18 Countries Successful NDA and ANDA drug registrations In good standing with theFDA, PMDA... pharmaceutical manufacturing professional who is ready to take on greater leadership responsibility and play a key role in the...
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...
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...
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...
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...