Our success-pushed crew will write and carry out your GMP method, teach you and stick with you until finally you pass your GMP certification audit.

“Larsen Packaging Products is appreciative to Kellerman Consulting and our Get hold of Tim Grady for aiding us in getting our GMP certification. Tim walked this journey with us from beginning to conclusion and was usually accessible to remedy any thoughts and help us in establishing treatments, sorts, and many others.

Our groups have many years of working experience in reagent improvement and IVD-Qualified manufacture, in addition to a established reputation generating GMP-quality ancillary reagents for cell therapy customers.

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which were significant on the profitable completion of this process. I'd very endorse Kellerman Consulting for just about any of one's consulting requirements since they were being very Skilled and ensured that every one items were addressed just before our audit. “

Commissioning, Qualification & Validation We get the job done with our shoppers to create scalable source ideas to assist validation efforts all over the job lifecycle. Whether it is drafting protocols to execution and compilation of data packs, our methods have you covered.

We provide registration tactics and support with submissions for corporations who would like to provide merchandise for the Australian market but are Doubtful with the regulatory prerequisites.

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Regardless of whether you’re while in the item setting up, development or pharmaceutical lifecycle management phase or have to have a remediation approach for the compliance crisis, Regulatory Compliance Associates will guidebook you thru just about every pharmaceutical consulting action from the regulatory approach.

Check out expert CVs » Start a advisor lookup » Be a part of our consulting group. For the click here FDA Team, we're often searching for major talent to improve our network. If you can bring experience and new perspectives to our consulting team, we invite you to ship us your resume.

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