The aim of provider qualification is, about the a single hand, to safeguard supply chains through the merchandise lifecycle and, Conversely, to be sure robust inner procedures in compliance with the relevant regulatory requirements.
We’ll get the job done together with you to apply your GMP certification application, making sure you understand how to operate it and that you pass your subsequent audit.
IQVIA Decentralized Trials provide purpose-built clinical expert services and technologies that engage the proper patients where ever They are really. Our hybrid and totally Digital solutions are utilized a lot more than any Other folks.
Anxious your high-quality procedure will not mirror FDA expectations? Connect with previous FDA and field professionals which have intensive familiarity with FDA's present-day inspection techniques and anticipations that transcend the phrases of regulation.
Customized answers: No two businesses are the exact same, and we regard these variances by tailoring our consulting providers to the Business’s distinctive wants, conditions, and problems. We offer bespoke alternatives created to tackle your particular GMP compliance hurdles head-on.
The definition with the scope to become analyzed will be the duty of the customer. In case of detailed hole analyses, the GMP/GxP marketing consultant accomplishing the analysis may well propose clarification of interfaces or transitions between person analyses.
Commissioning, Qualification & Validation We function with our clients to establish scalable useful resource programs to assistance validation efforts all through the job lifecycle. Whether it's drafting protocols to execution and compilation of data packs, our resources Have you ever lined.
Our solutions are backed by a Total Quality Guarantee. If for almost any rationale, you happen to be dissatisfied with any support, We're going to supply you with an entire refund.
With more than twenty years of expertise with FDA, Wellness Canada, EU and world wide regulatory businesses all over the check here world, Regulatory Compliance Associates® offers leading pharmaceutical consultants. We’re among the list of couple pharma consulting organizations which can help you navigate the troubles affiliated with field rules.
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Laura with Kellerman Consulting is just marvelous. She is rather useful, uncomplicated to operate with and acquired us through our GMP audit having a a lot better score than we predicted. Also, the Business of all the paperwork Kellerman Consulting supplied us with is excellent.
We’re scientific improvement industry experts focused on encouraging now’s most ground breaking biotech and specialty pharma organizations more info acquire their very best Concepts from benchtop to bedside.
Our High quality procedure be certain that our consumers acquire customized studies with areas most relevant to their functions.
They can be a pleasure to work with. I have a great deal to try and do and am incredibly occupied – they outlined all the things out in a very acceptable vogue and bought The work carried out inside the precision and detail we needed it for being. I'd work with them once more!