Kellerman Consulting came to the rescue for me just after working with A different competitor who remaining me at the hours of darkness. I was so relieved to locate a liable, professional consulting organization who could support a different operator out in developing a full blown HACCP approach - and educate me together the way!
We’ll work together with you to definitely employ your GMP certification plan, making certain you understand how to run it and you pass your upcoming audit.
While these troubles are exterior variables can’t be managed by any corporation. The one particular and only way to stay sustainable is by a structured Manufacturing Excellence Tactic.
Kellerman Consulting’s GMP consultants offer a prepared quality & food stuff protection manual that's customized to your merchandise, course of action and operation. We offer top quality consulting and food basic safety coaching according to present FDA regulatory needs and customized to your GMP certification plan that you're wishing to receive Accredited versus.
Consulting assistance: Our marketing consultant will Consider your personal situation and provide you with an expert assessment.
The definition of the scope to be analyzed is the accountability from the customer. In case of in depth gap analyses, the GMP/GxP advisor executing the Investigation may well endorse clarification of interfaces or transitions involving unique analyses.
From R&D to provide chain and functions to each aspect of commercialization, pharma and biotech organizations really need to execute flawlessly throughout all Proportions when they hope to get.
Regulatory affairs is Regulatory Compliance Associates spine. We exceed other pharma consulting companies with market experts seasoned in complexities from the pharmaceutical and biopharmaceutical industries.
In a very protocol or maybe a report of that dialogue consumer can more info get comprehensive descriptions of any inconsistencies or deviations observed. Also, the furnished technical and organizational principles were followed and scrutinized on the basis of recognised or defined approach parameters.
Our results-driven crew will generate and employ your GMP application, coach you and stick with you till you pass your GMP certification audit.
Read through our tendencies report from the couple of years back again to evaluate important pharma considerations that are still at Perform during the field.
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Get in contact with us now and convey to us in which techniques of GMP notion improvement you would like assistance. We're going to promptly supply you with a suggestion for consulting solutions or generation of a concept. Jointly here we discover The perfect alternatives on your challenge!
Our pharma consultants learn how to companion with govt, lawful, and communication groups. Every RCA pharma consulting Specialist will create a reaction that could be recognized through the regulatory company and become sensible to execute.