Over the item lifetime cycle of a medicinal product, top quality requirements boost constantly from research and advancement through the different medical phases to market maturity.
We'll overview your documentation and visit your facility, detect gaps with your current software and facility functions, and we will allow you to fill Those people gaps as a way to move your audit.
I had arrive at Shelby Foods just four months ahead of the First BRCGS audit and experienced very little strategy what was required for BRCGS. Brian labored with me and patiently answered all my questions until finally I understood every thing.
I might extremely endorse Kellerman Consulting to any person taking into consideration this sort of certification for their Firm”.
Our pharmaceutical consulting Gurus will make a customized tactic dependant upon your solution and business’s particular person needs. Our regulatory compliance consumers involve:
Zero Effect: To produce the manufacturing system, merchandise, ecosystem pleasant and adequate for social very well currently being and sustainability on the surroundings.
Regulatory affairs is Regulatory Compliance Associates backbone. We exceed other pharma consulting businesses with field professionals professional in complexities of your pharmaceutical and biopharmaceutical industries.
Worldwide offer chain disruption and API scarcity will force the sector to diversify sourcing areas and establish new supplier networks – all while giving authentic-time, comprehensive-products visibility and traceability.
Nevertheless sophisticated your lifetime sciences offer chain, our professional professionals are here to help you attain and retain close-to-finish GMP compliance in step with present-day and emerging laws.
"Its a lengthy proven undeniable fact that a reader might be distracted by the readable material of the website page when"We've been happy to inform that one get more info highly experienced." For just about any need concerning on-internet site, compose to us more info at [email protected] OR Phone AT 9878880408
Laura with Kellerman Consulting is simply terrific. She is very valuable, effortless to operate with and got us by our GMP audit having a much better rating than we expected. Also, the Firm of each of the paperwork Kellerman Consulting supplied us with is superb.
Our good quality, production, CAPA, and supplier top quality professionals conduct thorough process testimonials and analyses to make certain all compliance gaps are shut it doesn't matter in which They might be.
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We can offer GMP providers for specific niche remedies to your troubles in addition to extensive deals that cover all GMP needs arising in the context of pharmaceutical production things to do.