“Kellerman Consulting acted as being a coach for our new QC hire, so we benefited from that plus the prosperous preparation to the SQF audit. We received a ninety eight% within the audit. That ought to speak for by itself.
Zero Decline: Zero Reduction is undoubtedly an goal/attempt to beat these types of losses or minimize their effect approximately excellent extent in an effort to lessen the producing Price.
GMP consultants with QA encounter understand how Every single department while in the Group interacts Using the producing procedures and methods. QA specialists have a complete image in your mind when designing a quality administration process and so are particularly knowledgeable in federal, local, and Experienced criteria.
I would very advocate Kellerman Consulting to any person thinking about this kind of certification for his or her Business”.
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program have been fantastic. Through the audit it gave me self esteem knowing we had everything according to BRCGS specifications.
Law firms in search of pharmaceutical consulting company abilities from the remediation of warning letters, consent decrees, 483’s or import bans
We have now an A rating with GMP consultants BRCGS and I attribute that to Brian Kellerman and Kellerman Consulting for everything they may have done that can help our small business to more info obtain the certification. Their initial assessment of our firm, the files, and information offered to produce our
Partnering with Some others to share information, medicine and methods while anticipating tendencies and regulatory modifications will help make certain sustainability within the significantly proof-based mostly, results-focused sector.
In the event that medicinal solutions shall be produced for just a clinical demo, a manufacturing authorisation as well as a corresponding GMP certificate are currently needed for this intent.1
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- The audit report shall be then available in our Audit report databases which may be accessible to any of your respective shoppers. We'll receive permission from the supplier before sharing studies towards the purchasers.
With much more than twenty years of knowledge with FDA, Health Canada, EU and world wide regulatory agencies around the globe, Regulatory Compliance Associates® presents major pharmaceutical consultants. We’re one of the few pharma consulting businesses which will help you navigate the challenges affiliated with business rules.