Regulatory Compliance Associates good quality assurance companies consist of good quality industry experts with working experience spanning big corporations and start-ups. Our pharmaceutical consulting business is familiar with firsthand how to attain, manage, and boost top quality. Last but not least, our regulatory compliance companies crew excels in transferring steady advancement expertise towards your Firm.
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Kellerman Consulting’s GMP consultants supply a penned high quality & meals basic safety guide that's personalized on your product, process and operation. We provide excellent consulting and food security teaching In accordance with recent FDA regulatory prerequisites and personalized to the GMP certification scheme that you are wishing to obtain Accredited against.
“We understood if we wanted to get in which we needed to choose our business and securing some of These massive consumers, that we necessary to have SQF certification. Once i very first began speaking with Kellerman Consulting, I knew they were gurus.
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Commissioning, Qualification & Validation We perform with our clientele to create scalable useful resource plans to assistance more info validation efforts all through the project lifecycle. Whether it's drafting protocols to execution and compilation of knowledge packs, our assets Have you ever included.
uncommon diseasecell & gene therapyoncology & hematologydermatologymedtechneurosciencepediatricsanalgesiawomen’s well being Major just how
In the protocol or possibly a report of that dialogue purchaser will get in-depth descriptions of any inconsistencies or deviations noticed. Also, the offered technological and organizational read more concepts had been followed and scrutinized on The premise of identified or described system parameters.
This and the precise description of the requirements and processes will allow the enough adaption of the resources to the actual need to have of your GMP procedure.
R & D Presents intellectual home and regulatory advice to create a sustainable, compliant product to develop price.
STRATEGIC DRUG DEVELOPMENT Generate method via expert regulatory insight and assistance Business-major therapeutic and useful place gurus assistance shoppers glean applicable regulatory insights from earth-class knowledge, enabling serious-time willpower and evaluation of time, cost and danger.
Our Top quality technique make sure our clientele obtain individualized experiences with locations most applicable to their functions.
Our integrated consulting solution can also present both equally program- and analyze-amount technique such as sensible asset valuation. Find out more about our capabilities in: