“Kellerman Consulting acted being a coach for our new QC seek the services of, so we benefited from that in addition to the thriving preparation for your SQF audit. We acquired a 98% within the audit. That should discuss for by itself.
Our workforce of authorities has productively performed many hole analyses in over the last 20 years and provides this consulting provider for all GMP units.
Proprietary talent collection of previous FDA and marketplace industry experts amplified by a company society of responsiveness and execution. About Overview
Kellerman Consulting’s GMP consultants supply a prepared quality & food safety manual which is personalized on your products, approach and operation. We provide high-quality consulting and foods safety education Based on latest FDA regulatory demands and custom made to your GMP certification scheme that you're wishing for getting Accredited towards.
Our staff of skilled regulatory researchers can publish the nonclinical, clinical, and CMC sections in CTD and standard format for the new drug and biologic apps.
The success of paperwork and on-site checks are documented as well as observations and recognized deviations regarding GMP here prerequisites are talked about.
that were significant towards the successful completion of this process. I'd highly recommend Kellerman Consulting for just about any of your respective consulting demands since they have been pretty Specialist and ensured that every one objects were dealt with prior to our audit. “
Regardless of your following project, our GMP consultants work carefully with our Architects, Engineers, Experts and ex producing personnel to help you layout your subsequent project, we routinely perform with exterior contractors, tools suppliers and builders.
The EY R&D Workbench for Pharma is a singular tech Remedy for powerful job setting up management, workflow and problem and query monitoring inside the R&D setting.
Using a GMP advisor on board, your Group can concentrate on its Main operations while guaranteeing compliance is meticulously managed.
A staff of long-lasting GMP consultants, specialised in numerous fields of competence, supports you in the duties and problems with experience and foresight.
We leverage Sophisticated know-how and a strong Get hold of community to hire expertise that will increase new Proportions to your organization.
Developing IQVIA’s positions read more on key trends during the pharma and everyday living sciences industries, having a target EMEA.
Clarkston supports late-stage medical companies on their own route to commercialization. Leveraging deep marketplace skills and acknowledged functional and company method leadership to help companies changeover from development to commercialization, making sure sustainable, lengthy-time period expansion.