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As your companions, Regulatory Compliance Associates can negotiate the likely minefield of regulatory compliance and regulatory due diligence with Perception, hindsight, and also the distinct benefit of our distinctive expertise and knowledge.
The good GMP consultants might endorse modern technologies and proven processes to attain larger top quality plus more productive processes. Choosing FDA GMP consultants can reduce pricey errors For most makers.
Our interim managers are really flexible, and their perform is charged on hourly basis only. A set price tag supply such as all incidentals may be submitted on Specific ask for.
Qualification of premises, facilities and devices plus the planning on the corresponding documentation
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which were critical to the effective completion of this process. I'd personally remarkably advocate Kellerman Consulting for just about any within your consulting requires since they were very Specialist and ensured that each one objects were being addressed ahead of our audit. “
Regulation companies trying to find pharmaceutical consulting firm expertise from the remediation of warning letters, consent decrees, 483’s or import bans
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Whether or not you’re inside the solution arranging, progress or pharmaceutical lifecycle administration phase or have to have a remediation approach for the compliance crisis, Regulatory Compliance Associates will information you through each and every pharmaceutical consulting action from the regulatory procedure.
All of our complete-time GMP consultants are very well-versed in Kellerman Consulting’s repeatable and trusted process. Our staff’s collaborative society provides you with the advantage of our collective encounter with many more info profitable outcomes.
Will need to build or increase your Quality Assurance crew with top talent? We enable A huge number of everyday living science organizations outsource their QA tasks and fill specialised roles by way of handy team augmentation and recruitment.
- When report essential on urgent basis to guidance the availability, regulatory submissions and so forth., When manufacturing website can’t accommodate the audit because of chaotic plan, When travel restriction; Sponsor will get Positive aspects by buying our IGAP here experiences from our report database, In addition our customers only shell out a little fraction of the costs typically connected to conducting a provider audit.