We presents turnkey good quality alternatives and concentrates on featuring exceptional cost efficiency, even though keeping best high-quality requirements for our Consumers.
We’ll operate together with you to definitely apply your GMP certification software, ensuring that you understand how to operate it and that you choose to pass your next audit.
The good GMP consultants could endorse modern day systems and verified procedures to attain bigger high-quality and more economical processes. Hiring FDA GMP consultants can reduce high-priced errors For most suppliers.
For a passionate pupil of industry, Ana is remarkably pushed and devoted to bringing price to the two clients as well as their provide chain partners alike.
Just before this, an proper good quality management process have to have been founded, which demonstrates acceptable measures to make sure the right high-quality and basic safety of the medicinal products according to EU criteria.
Unparalleled knowledge: Our consultants have broad sector encounter and an insider’s standpoint from their time as GMP inspectors. They've got stood on either side of your GMP compliance equation, furnishing them with a novel knowing that informs each support we read more offer.
Design overview is really a effectively-established GMP consultancy assistance. By this treatment prepared or already created technical products and installations are approved on high-quality by design and style criteria, suitability and GMP compliance.
Regulatory Compliance Associates pharma regulatory consultants will acquire an extensive evidence guide of documented evidence demonstrating the corrective motion taken to remediate non-compliant challenges.
Making with a rich historical past of acquiring AI for healthcare, IQVIA AI connects the ideal details, technological know-how, and experience to handle the special wants of healthcare. It is what we contact Health care-grade AI.
That has a GMP expert on board, your Business can focus on its core operations even though guaranteeing compliance is meticulously managed.
Laura with Kellerman Consulting is simply wonderful. She is rather practical, straightforward to work with and acquired us as a result of our GMP audit with a a lot better score than we predicted. Also, the organization of each of the paperwork Kellerman Consulting supplied us with is excellent.
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It’s a pharma consultancy Established by regulatory compliance executives from the pharmaceutical field. Just about every pharmaceutical field consultant on the Regulatory Compliance Associates workforce appreciates the distinctive inner workings of the regulatory process.