GMP consultancy for Dummies
GMP consultancy for Dummies
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Whether or not you’re during the merchandise preparing, progress or pharmaceutical lifecycle management stage or have to have a remediation system for a compliance crisis, Regulatory Compliance Associates will tutorial you through every single pharmaceutical consulting action of the regulatory system.
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A lot of our pure scientists and engineers are familiar with remaining in management positions and, if expected, also within your company.
I would highly endorse Kellerman Consulting to everyone looking at this type of certification for their Business”.
Our pharmaceutical consulting Professionals will make a customized technique based on your item and enterprise’s personal needs. Our regulatory compliance clientele involve:
Unparalleled skills: Our consultants have huge sector encounter and an insider’s viewpoint from their time as GMP inspectors. They've got stood on either side in the GMP compliance equation, offering them with a novel being familiar with that informs each individual company we offer.
“Larsen Packaging Merchandise is appreciative to Kellerman Consulting and our Speak to Tim Grady for aiding us in obtaining our GMP certification. Tim walked this journey with us from beginning to close and was often accessible to respond to any inquiries and guide us in acquiring techniques, varieties, etc.
Biopharma Launch Edge gives a comprehensive read more selection of start providers designed to help provide groundbreaking results, by get more info giving a more quickly, less difficult and more productive launch method.
The best way to design and style an air managing procedure meeting the necessities of place cleanliness classification and environmental defense?
Our effects-pushed staff will publish and put into action your GMP software, train you and stick with you until eventually you move your GMP certification audit.
Tim and Brian rallied all-around me and built sure I was wanting to satisfy the obstacle head on. From creating and reviewing paperwork, to educating a complete amateur, to executing a mock audit upfront, the Kellerman group manufactured absolutely sure we ended up Completely ready don't just to go, but to attain a 91 on our very first audit. I could not recommend them a lot more highly”!
All of our whole-time GMP consultants are very well-versed in Kellerman Consulting’s repeatable and dependable process. Our staff’s collaborative lifestyle will give you the advantage of our collective working experience with numerous productive results.
Our pharma consultants understand how to associate with executive, authorized, and interaction teams. Each and every RCA pharma consulting Qualified will develop a response that will be approved via the regulatory company and be sensible to execute.
We generate custom made jobs in compliance with FDA / USDA regulatory demands and GMP certification specifications For each small business we provide.