STRATEGIC DRUG Advancement Travel approach by qualified regulatory Perception and information Business-leading therapeutic and useful area experts support consumers glean pertinent regulatory insights from globe-course facts, enabling actual-time resolve and analysis of time, Price and risk.
With everlasting placement from The FDA Group, you'll be able to attain 3 Major aims: lower the cost of talent identification and supply, acquire the guaranteed excellent of recent hires, and mitigate the risks of recruiting new staff.
With a lot more than twenty years of practical experience with FDA, Health and fitness Canada, EU and world wide regulatory businesses worldwide, Regulatory Compliance Associates® provides main pharmaceutical consultants. We’re among the couple pharma consulting businesses which will help you navigate the troubles related to market polices.
We assistance web site for effectively passing inspections and design post-inspections remediation plans to ascertain & update GMP compliance and sustain approval for the item with Pharmexpert's personalized and cost-helpful plans for Quality Administration for Pharmaceuticals, Bio-Pharma and MD.
We’ll work alongside you to carry out your GMP certification application, making sure you know how to run it and which you pass your future audit.
Tim and Brian rallied all over me and made positive I used to be willing to meet the obstacle head on. From crafting and examining files, to educating a complete novice, to performing a mock audit ahead of time, the Kellerman group produced positive we ended up All set not simply to go, but to attain a ninety one on our to start with audit. I couldn't advocate them additional hugely”!
- Signing up for our IGAP plan/ Audit report library is free for suppliers/manufacture. Our seasoned and capable auditor will complete full web-site audit of provider masking significant number of molecules/merchandise (if not previously carried out) without having cost to provider and in depth audit report shall be organized.
“Kellerman Consulting was here Specialist, successful, and proceeds to show their assist and advice even after the GMP audit”.
A GMP consultant offers the expert guidance needed to navigate the complexities of GMP compliance. Their in depth understanding of community and Global polices, sector finest techniques, and the most recent updates in the sector equips your Corporation Along with the instruments to fulfill and exceed regulatory benchmarks.
Law corporations looking for pharmaceutical consulting agency skills within the remediation of warning letters, consent decrees, 483’s or import bans
We could develop a breadth of pharmaceutical formulations throughout An array of indications. Our impressive tactic integrates drug product or service growth with medical analysis. We labored on pharma consultancy optimizing above 1,five hundred molecules in the slightest degree levels of drug advancement.
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If you already have a facility layout, we can provide an independent GMP evaluation to be sure that all of the vital facts are coated.
GMP consultants not only assistance keep compliance, but Additionally they discover prospective regions of risk prior to they turn into substantial challenges.