Kellerman Consulting arrived to your rescue for me after working with A different competitor who remaining me in the dark. I was so relieved to locate a dependable, experienced consulting agency who could support a completely new operator out in creating a complete blown HACCP prepare - and instruct me along the best way!
The pharmaceutical marketplace is governed by stringent restrictions to ensure the protection, efficacy, and quality of merchandise. Superior Production Exercise (GMP) compliance is non-negotiable and it is central towards the operational results of any Corporation During this sector.
- And when on-web site visits are not feasible, our adaptable shipping and delivery product allows us to ensure enterprise continuity and the bottom probable impact on all auditing operations, we conduct audits remotely by using documentation opinions and SME conversations According to Pharmexpert methodology. And When onsite audit feasible, We strategy for onsite audit.
Kellerman Consulting’s GMP consultants offer a penned excellent & food items protection manual that is definitely tailor-made for your item, system and operation. We provide good quality consulting and foods safety coaching In line with current FDA regulatory demands and custom-made on the GMP certification plan that you'll be wishing to obtain Licensed versus.
Empowering patients to personalize their Health care and connecting them to caregivers has the opportunity to change the care supply paradigm. IQVIA and Apple are collaborating to carry this exciting future of individualized treatment straight to units clients have already got and use.
Unparalleled knowledge: Our consultants have broad field experience and an insider’s viewpoint from their time as GMP inspectors. They have got stood on both sides from the GMP compliance equation, furnishing them with a unique understanding that informs every assistance we provide.
The QA Division is recognized for policing the regulated procedures for the corporation. They guarantee compliance is achieved. To be able to operate in the QA Division, an check here individual necessitates thoroughness and a focus to element. There is not any substitute for QA expertise.
Company Setting techniques for development via restructuring, effectiveness enhancements and scaling up of functions.
The EY R&D Workbench for Pharma is a website novel tech Alternative for helpful task organizing management, workflow and issue and question monitoring inside the R&D setting.
On ask for, the respective regulatory authority will perform an on-site inspection to validate compliance with countrywide law and EU GMP prerequisites.
Tim and Brian rallied all around me and produced positive I had been prepared to meet up with the challenge head on. From creating and reviewing paperwork, to educating an entire amateur, to performing a mock audit upfront, the Kellerman workforce produced guaranteed we were being ready not merely to move, but to score a ninety one on our first audit. I couldn't advocate them extra remarkably”!
We leverage Highly developed technology and a powerful Make contact with network to hire expertise that could increase new Proportions to your organization.
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This involves one example is, qualification, validation and deviation or adjust management. The Gap Assessment can be an Energetic comparison on the proven recent condition with the prerequisites specified by regional or Worldwide GMP regulations.