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As your associate, we are able to negotiate the probable assessment minefield of regulatory compliance products and services with insight, hindsight, along with the very clear advantage of our breadth and depth of knowledge and regulatory compliance consulting. We offer the next pharma consulting regulatory affairs solutions for pharmaceutical corporations.
Kellerman Consulting’s GMP consultants supply a written good quality & food basic safety handbook that is certainly personalized in your products, course of action and operation. We provide excellent consulting and food items protection teaching In line with existing FDA regulatory prerequisites and customized into the GMP certification scheme that you'll be wishing to receive Licensed from.
Custom-made solutions: No two organizations are a similar, and we regard these dissimilarities by tailoring our consulting services towards your Firm’s exclusive requires, conditions, and worries. We offer bespoke answers intended to tackle your particular GMP compliance hurdles head-on.
“Kellerman Consulting was Expert, effective, and continues to point out their assistance and guidance even once the GMP audit”.
Whether you’re during the merchandise planning, progress or pharmaceutical lifecycle here management phase or require a remediation strategy to get a compliance disaster, Regulatory Compliance Associates will guide you through just about every pharmaceutical consulting stage of your regulatory method.
We also have quite a few inner compliance actions to ensure that data is protected from exterior threats, such as independent penetration tests.
Along with parenterals PJC Pharma Consulting can supply a variety of assist for other click here dosage types, from applicant range as a result of to NDA/MAA submissions, equally for new chemical entities and products line extensions (PLEs) of many oral dosage formulations: Tableting
Featuring a strategic combination of field acumen, world wide compliance, and therapeutic expertise to aid make sure your impressive Strategies aren’t hindered by confined means.
Tim and Brian rallied all around me and built certain I was ready to meet the problem head on. From creating and examining files, to educating an entire amateur, to undertaking a mock audit ahead of time, the Kellerman team made confident we have been Prepared not simply to go, but to score a ninety one on our very first audit. I could not recommend them much more remarkably”!
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As these documents are definitely the vital to an economical and mistake cost-free operation from the GMP unit, they need to match to one another and to the scale of the customer side.
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