Layout trials with enriched client populations and alter patient recruitment requirements to improve precision and velocity
“We partnered with Kellerman Consulting extremely early on during the SQF certification procedure, and by counting on their skills and methodical approach to gathering, compiling, and organizing the necessary documentation, we were being effective in getting our certification.
GMP consultants with QA working experience understand how Every single Section during the organization interacts Along with the production processes and units. QA specialists have a complete image in mind when coming up with a top quality management method and they are incredibly knowledgeable in federal, neighborhood, and professional criteria.
Elevate business versions with precision and velocity making use of AI-driven analytics and technological innovation that illuminate hidden insights in details.
Zero Supply / Failure: To accomplish the job within the direct time with out failure in Inventory time, WIP storage, Logistics Price tag, and mapping in the steps a corporation requires to complete a specific approach.
In combination with your created meals security & high quality system, every one of our customers receives usage of a package of personnel foods protection instruction video clips, quizzes, and coaching logs that aren't publicly obtainable at no extra Value in both English and Spanish.
We're able to not only knowledge these international rules, but additionally of delivering strategic solutions that take into account both equally worldwide and native compliance requirements.
Regulatory Compliance Associates pharma regulatory consultants will establish an extensive evidence e book of documented proof get more info demonstrating the corrective motion taken to remediate non-compliant concerns.
Having said that sophisticated your life sciences offer chain, our professional gurus are here to help you accomplish and sustain close-to-stop GMP compliance in line with present and emerging regulations.
The fashionable era on the point out of art manufacturing amenities (planet-class facility) is developed and constructed in accordance with stringent cGMP requirements.
Laura with Kellerman Consulting is simply great. She is incredibly handy, effortless to operate with and got us by means of our GMP audit which has a much better rating than we predicted. Also, the Firm of every one of the paperwork Kellerman Consulting supplied us with website is excellent.
Combining really properly trained specialists and thoroughly refined processes with our planet-course technologies.
Through mock inspections we’ll check that all is appropriately, and goal remediation as wanted.
An essential prerequisite to the economical and simple software of the quality assurance applications would be the deep understanding about alternatives and variation.