Laura with Kellerman Consulting is just great. She may be very valuable, uncomplicated to operate with and got us through our GMP audit by using a far better score than we expected. Also, the Corporation of all of the documents Kellerman Consulting furnished us with is superb.
This functional expertise, coupled with our comprehensive knowledge of community and worldwide rules, positions us as an unmatched asset to any organization looking for GMP compliance.
GMP refers into a set of laws, standards, and rules that relate for the processing of drug substances and solutions, professional medical products, in vivo As well as in vitro professional medical products categories, and meals products.
Use our committed workforce for guidance with system validation and regulatory affairs, that will help your reagent transition from Preliminary submission to marketplace authorization. We’ll present full documentation each stage of that way.
Our dedicated venture management staff performs closely along with your Management staff to determine and observe venture milestones, timetable activities, information means, and report on achievements.
Involved your quality process does not mirror FDA expectations? Link with previous FDA and sector professionals who may have intensive knowledge of FDA's latest inspection techniques and expectations that transcend the text of regulation.
Discover the gaps inside of your company’s present Management Process in an effort to fulfil the best procedures established with the Intercontinental specifications.
Possessing an auditor come across non-compliances on your website can be a pretty pricey way to discover that you simply don’t hold the depth of data or knowledge in-home to deal with GMP compliance.
I had arrive at Shelby Foods just check here four months ahead of the Original BRCGS audit and had hardly any plan what was necessary for BRCGS. Brian labored with me and patiently answered all my concerns right until I understood every little thing.
On top of that, each Regulatory Compliance Associates pharma consulting Professional understands compliance enforcement. We’ll prepare an extensive pharma consulting strategy to guide inside your remediation endeavours, drive constant improvement, and preserve regulatory compliance Using the rules.
Our quality, manufacturing, CAPA, and supplier quality specialists carry out extensive method opinions and analyses to be certain all compliance gaps are shut it does not matter the place They might be.
Education We associate with helpful businesses and educators to improve scholar outcomes and Mastering models—from K-12 as a result of increased training—regionally, nationally, and globally.
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