Several providers opt to seek the services of consultants to deliver small business assistance companies to thoroughly put together for certification audits . Kellerman Consulting will publish & put into action foods security and excellent applications which can be customized towards your solution and course of action.
We recognize the various troubles and issues you experience with your strategy to obtaining GMP compliance in the pharmaceutical, biotechnology, ATMP and health-related machine manufacturing industries - and we develop useful, achievable and price-helpful options for you.
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Concerned your excellent process doesn't mirror FDA expectations? Link with previous FDA and business gurus that have substantial expertise in FDA's present inspection procedures and anticipations that go beyond the phrases of regulation.
Normally the look overview setup is prepared by one particular GMP specialist. The files then are checked and evaluated in presentation manner by two or a few specialists.
We have an understanding of the complexities of operating a existence science company and have areas of experience that come with every single facet of R&D, functions, regulatory affairs, high quality, and manufacturing.
This practical experience allowed Ana to gain an in-depth knowledge of the regulatory authorities’ expectations and an extensive familiarity with the EU and US GMP laws. She’s also done GMP inspections to 3rd party international locations on EMA’s behalf.
Our solutions are backed by a complete Quality Guarantee. If for virtually any purpose, that you are dissatisfied with any company, We are going to provide you with an entire refund.
Kellerman Consulting has supported many hundreds of shoppers nationwide to successfully go their regulatory inspections as well as their GMP and cGMP certification audits.
Creating IQVIA’s positions on crucial tendencies while in the pharma and life sciences industries, by using a center on EMEA.
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We’re clinical enhancement gurus focused on encouraging these days’s most progressive biotech and specialty pharma companies choose their ideal Tips from benchtop to bedside.
Business Making use of hands-on earlier knowledge together with market place investigate capability, can guide organizations productively to perhaps viable marketplaces . examine additional
In case you’re an bold get started-up, a disruptive entrepreneur, a following era chief of a loved ones enterprise or maybe a transformative get more info CEO, we can help you reach your progress ambitions and produce a legacy being pleased with.