Ana’s integrated eyesight of Pharmaceutical Good quality Techniques serves her properly in collaborating with inner and exterior customers to harmony compliance with sensible, in shape to be used options.
Whether you'll need personnel payment for parental leave or for other quick-expression vacancies - we give you the ideal interim manager for every need profile.
However these difficulties are external elements can’t be managed by any enterprise. The just one and only way to remain sustainable is by a structured Manufacturing Excellence Method.
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Our crew of expert regulatory researchers can compose the nonclinical, medical, and CMC sections in CTD and conventional structure to your new drug and biologic apps.
“Kellerman Consulting was professional, effective, and continues to indicate their support and direction even once the GMP audit”.
- And when on-web site visits aren't feasible, our versatile shipping and delivery design makes it possible for us to ensure enterprise continuity and the bottom possible impact check here on all auditing functions, we accomplish audits remotely by means of documentation assessments and SME discussions According to Pharmexpert methodology. And When onsite audit possible, We plan for onsite audit.
Global offer chain disruption and API scarcity will power the sector to diversify sourcing areas and establish new supplier networks – all when providing true-time, full-solution visibility and traceability.
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Guarantee the quality of your products by creating a QMS. Valicare's professionals will aid you with QM consulting, doc preparation & implementation.
Tim and Brian rallied about me and created absolutely sure I used to be ready to fulfill the obstacle head on. From writing and reviewing files, to educating a whole newbie, to performing a mock audit upfront, the Kellerman workforce made guaranteed we ended up Prepared not only to go, but to attain a ninety one on our 1st audit. I could not endorse them a lot more extremely”!
All of our whole-time GMP consultants are well-versed in Kellerman Consulting’s repeatable and reputable process. Our more info crew’s collaborative society gives you the benefit of our collective practical experience with countless effective results.
"We try to assist boost results and produce a more healthy, additional sustainable world for men and women just about everywhere.
Our experts prepare all big regulatory submissions and provide substantial high-quality Handle overview for all trial-linked documentation, such as: