Do you need aid or assistance on one or more of such topics? Our seasoned specialists will speed up the entry of one's solution in the pharmaceutical/biotech marketplace.
Their very first-hand practical experience and insights from the sphere set us aside, allowing for us to provide Remarkable support grounded in simple expertise.
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“We realized if we wanted to get exactly where we planned to go along with our business and securing a number of Individuals massive customers, that we needed to have SQF certification. When I 1st started off speaking with Kellerman Consulting, I understood they had been authorities.
That is what an average method seems like: The GMP advisor very first checks the company-specific documentation and results in a gap analysis plan. Based upon this hole Investigation plan, the analysis on-web page will probably be done.
This knowledge permitted Ana to realize an in-depth understanding of read more the regulatory authorities’ anticipations and an extensive knowledge of the EU and US GMP restrictions. She’s also executed GMP inspections to third party countries on EMA’s behalf.
Style, construction, and commercialization of cleanroom facilities more info are costly processes that involve detailed preparing and resources. In addition, it dictates the quality and compliance of items that are to be manufactured and their profitability more than the long term.
Now we have an A rating with BRCGS and I attribute that to Brian Kellerman and Kellerman Consulting for anything they have got carried out to help you our business to obtain the certification. Their First evaluation of our business, the files, and data supplied to generate our
Our experts performs third party evaluation and gap Assessment which has a quantified Software to evaluate the corporation’s point out of regulatory compliance. We help the companies in developing CAPA for deficiencies elevated by regulatory inspections.
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We have concluded much more than seven hundred+ Seller/Provider Qualification audits. Locally dependent consultants in wider geography so productive high-quality of work without language barrier and journey restrictions.
Via mock inspections we’ll Check out that each one is as it should be, and goal remediation as necessary.
“They are so Expert and it absolutely was just a real enjoyment Performing through every little thing. I'd personally Completely advocate Kellerman Consulting. I have already got. When men and women ask me with regards to the SQF consulting method, I would not wait to state," surely simply call Kellerman Consulting'' ” .