Ana’s built-in vision of Pharmaceutical Good quality Units serves her nicely in collaborating with inside and exterior consumers to balance compliance with practical, match for use methods.
Gap Evaluation is often a classical consulting tool to align The present With all the goal standing. It relates both to your complete GMP procedure of the controlled corporation or to individual subareas.
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Regulatory Compliance Associates pharma regulatory consultants will establish a comprehensive evidence ebook of documented proof demonstrating the corrective action taken to remediate non-compliant concerns.
Kellerman Consulting held my hand just about every stage of just how (and have confidence in me I needed it)! Kellerman Consulting got me through all of my approvals having an straightforward to stick to HACCP plan that appeased a USDA regional supervisor.
You'll obtain venture administration solutions and we will stick with you until eventually you go your audit – whatever.
An inherent obstacle for firms is: how can we fail speedier? Financial investment in R&D, details, and analytics, and talent recruitment will add to All round field innovation for treatment method and prevention.
Law firms trying to get pharmaceutical consulting organization expertise in the remediation of warning letters, consent decrees, 483’s or import bans
Crank out and disseminate evidence that solutions important scientific, regulatory and industrial questions, enabling you to drive smarter conclusions and satisfy your stakeholder wants with self confidence.
"Its a protracted established indisputable fact that a reader will probably be distracted via the readable written content of a page when"We have been happy to inform that one very seasoned." For almost any requirement regarding on-web site, create to us at [email protected] OR Simply call AT 9878880408
Tim and Brian rallied all around me and manufactured guaranteed I had been willing to meet up with the challenge head on. From creating and reviewing files, to educating a whole novice, to doing a mock audit beforehand, the Kellerman group created positive we have been Prepared not only to go, but to attain a ninety one on our first audit. I couldn't advise them a lot more hugely”!
Being an extension of your GMP Auditing workforce, we’re able to conduct audits on your own behalf, utilizing your proven audit more info program or the ADAMAS approach, whichever operates ideal for your preferences.
Need to have to create or augment your Quality Assurance crew with top click here talent? We support 1000s of everyday living science organizations outsource their QA tasks and fill specialised roles by way of handy staff members augmentation and recruitment.
Our built-in consulting technique may provide each program- and analyze-level system including sensible asset valuation. Learn more about our abilities in: