By using a combined tenure across our businesses of nearly two hundred many years and our market-regarded scientific and technological knowledge, we assist to ensure the security of in excess of a hundred ninety million sufferers and healthcare practitioners all over the world annually.
The pharmaceutical field is ruled by stringent rules to ensure the safety, efficacy, and top quality of products and solutions. Superior Manufacturing Apply (GMP) compliance is non-negotiable and is particularly central on the operational achievement of any Corporation In this particular sector.
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GMP consultants foster an natural environment of ongoing advancement within your Firm. They offer education and guidance to make sure that your group is current with the most up-to-date compliance benchmarks.
Kellerman Consulting held my hand each and every phase of how (and belief me I needed it)! Kellerman Consulting obtained me by way of all of my approvals with the simple to abide by HACCP plan that appeased a USDA regional manager.
Regulatory affairs is Regulatory Compliance Associates spine. We exceed other pharma consulting businesses with sector authorities expert in complexities with the pharmaceutical and biopharmaceutical industries.
program had been excellent. Over the audit it gave me self-confidence recognizing we had every little thing in step with BRCGS demands.
Law corporations searching for pharmaceutical consulting organization know-how in the remediation of warning letters, consent decrees, 483’s or import bans
Now throughout growth and formulation, the initial compliance actions permanently Production Apply (GMP) need to be executed. These fundamentally consist of all GMP applicable topics which happen to be click here to generally be used on the threat-dependent tactic based on the respective improvement stage.
Our success-driven crew will write and implement your GMP program, practice you and stick with you till you go your GMP certification audit.
We more info understand the complexities of functioning a lifestyle science enterprise and have places of experience that come with every side of R&D, functions, regulatory affairs, good quality, and production.
All of our total-time GMP consultants are well-versed in Kellerman Consulting’s repeatable and reputable procedure. Our team’s collaborative society will give you the good thing about our collective encounter with many prosperous outcomes.
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We can give GMP solutions for unique specialized niche answers for your challenges in addition to thorough offers that include all GMP prerequisites arising inside the context of pharmaceutical manufacturing functions.