We received by means of our audit and we are very proud to own gained a 99.37% score. I are Doing work For numerous, a few years and it is extremely refreshing to operate with another person which can be so Qualified and do what they say they're going to do and nevertheless take care of individuals with kindness.
Zero Reduction: Zero Loss is undoubtedly an goal/attempt to beat this sort of losses or minimize their outcome as many as terrific extent as a way to decrease the manufacturing Price tag.
I'd arrive at Shelby Foods just four months ahead of the initial BRCGS audit and had little thought what was expected for BRCGS. Brian labored with me and patiently answered all my thoughts until finally I recognized every thing.
Working through the initial improvement exercise phase, candidate collection, via scale up and complex transfer to the factory network, our experience in validation and microbial assessment on the production approach, possibility assessments and clinical trial patterns could be invaluable when placed on your portfolio.
Qualification of premises, amenities and devices plus the planning in the corresponding documentation
We fully grasp the complexities of jogging a lifetime science enterprise and have areas of experience that come with each individual side of R&D, operations, regulatory affairs, high quality, and manufacturing.
Commissioning, Qualification & Validation We work with our shoppers to develop scalable source plans to help validation endeavours through the entire undertaking lifecycle. Whether it's drafting protocols to execution and compilation of information packs, our assets Have you ever covered.
Despite your future challenge, our GMP consultants operate carefully with our Architects, Engineers, Experts and ex production staff members that can help layout your upcoming undertaking, we routinely operate with exterior contractors, products suppliers and builders.
We don’t distribute ourselves thin across several industries. Alternatively, we give attention to providing a further, richer bench of daily life science expertise at the speed you would like. Our huge staff members of internal sources and prolonged world-wide network provide usage of experts anywhere you will need them.
"Its a protracted set up indisputable fact that a reader will probably be distracted via the readable articles of a website page website when"We have been happy to inform that just one hugely skilled." For just about any necessity relating to on-web site, produce to us at [email protected] OR CALL AT 9878880408
Laura with Kellerman Consulting is just terrific. She is extremely valuable, uncomplicated to work with and bought us as a result of our GMP audit which has a a lot better score than we expected. Also, the organization of every one of the files Kellerman Consulting furnished us with is great.
As an extension of one's GMP Auditing staff, we’re in the position to conduct audits on your behalf, utilizing your set up audit software or maybe the ADAMAS procedure, whichever performs finest for your needs.
It’s a pharma consultancy Established by regulatory compliance executives from the pharmaceutical industry. Every pharmaceutical field advisor to the Regulatory Compliance Associates crew is aware the one of a kind inner workings from the regulatory course of action.
Regulatory Compliance Associates High-quality consulting website involves assessments, system, implementations, personnel augmentations, and identification of excellent metrics to make sure ongoing advancement. Our pharma consultants realize the strategic pondering required to align your enterprise desires and objectives.