Do you want support or information on one or more of these subject areas? Our seasoned professionals will accelerate the entry of your respective products into your pharmaceutical/biotech market place.

“We partnered with Kellerman Consulting really early on inside the SQF certification process, and by relying on their experience and methodical approach to accumulating, compiling, and organizing the essential documentation, we had been profitable in gaining our certification.

- And when on-web site visits usually are not possible, our flexible shipping model will allow us to guarantee enterprise continuity and the lowest achievable effect on all auditing functions, we carry out audits remotely by using documentation testimonials and SME discussions According to Pharmexpert methodology. And When onsite audit possible, We plan for onsite audit.

An in-target take a look at The nice Production Apply (GMP) audit environment And just how the idea of distant or virtual audits, a reasonably new idea is being adopted.

Our staff of professional regulatory researchers can generate the nonclinical, clinical, and CMC sections in CTD and classic format on your new drug and biologic programs.

The outcomes of files and on-internet site checks are documented and the observations and discovered deviations concerning GMP needs are talked over.

“Larsen Packaging Items is appreciative to Kellerman Consulting and our Get in touch with Tim Grady for aiding us in acquiring our GMP certification. Tim walked this journey with us from beginning to stop and was normally accessible to reply any issues and assist us in creating strategies, varieties, etcetera.

Companies Solutions EY aids clientele build extensive-time period value for all stakeholders. Enabled by details and engineering, our services and answers deliver believe in as a result of assurance and support consumers transform, increase more info and work. Method by EY-Parthenon

Acquiring hosted FDA meetings, FDA pre-acceptance inspections and MHRA inspections, We've got a few years of encounter primary trans-national teams situated in Japan, Europe and the United States of The us as well as other Global marketplaces for progress of items with the Japanese and worldwide commercial marketplaces.

On ask for, the respective regulatory authority will carry out an on-web-site inspection to confirm compliance with nationwide regulation and EU GMP necessities.

Laura with Kellerman Consulting is just wonderful. She is incredibly practical, simple to operate with and received us by our GMP audit having a significantly better score than we anticipated. Also, the Group of the many paperwork Kellerman Consulting offered us with is superb.

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Get in connection with us now and notify us through which steps of GMP concept improvement you check here would like aid. We are going to promptly present you with a proposal for consulting providers or generation of an idea. Together we find the ideal options on your undertaking!

With more than 20 years of knowledge with FDA, Overall health copyright, EU and world wide regulatory companies all over the world, Regulatory Compliance Associates® provides major pharmaceutical consultants. We’re among the number of pharma consulting providers which can help you navigate the challenges connected to industry polices.