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Performing in the Preliminary progress action stage, prospect range, by scale up and technical transfer in to the manufacturing facility network, our expertise in validation and microbial evaluation on the manufacturing procedure, chance assessments and medical demo types may be invaluable when placed on your portfolio.
Kellerman Consulting held my hand each individual stage of how (and trust me I desired it)! Kellerman Consulting obtained me as a result of all of my approvals having an very easy to comply with HACCP prepare that appeased a USDA regional supervisor.
As well as your published food stuff safety & high-quality application, every one of our clients gets use of a bundle of personnel food items protection instruction videos, quizzes, and coaching logs that are not publicly offered at no added Charge in both of those English and Spanish.
Style and design critique is a perfectly-set up GMP consultancy support. By this course of action prepared or by now developed specialized tools and installations are approved on high-quality by style and design requirements, suitability and GMP compliance.
Regulation corporations seeking pharmaceutical consulting firm skills within the remediation of warning letters, consent decrees, 483’s or import bans
We try to assist strengthen outcomes and develop a much healthier, extra sustainable globe for persons all over the place.
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Examine our trends report from a couple here of years back to overview crucial pharma things to consider that are still at play during the field.
The applicable supervisory authority checks the legally compliant layout of your QMS and might only grant your business a authorization with the activity in problem if all processes are described in compliance Along with the polices.
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Our built-in consulting method can also offer equally software- and examine-stage tactic like practical asset valuation. Learn more about our abilities in: