Do you want guidance or information on one or more of such subject areas? Our seasoned experts will speed up the entry of your merchandise to the pharmaceutical/biotech market.
“We partnered with Kellerman Consulting very early on during the SQF certification process, and by counting on their expertise and methodical method of amassing, compiling, and organizing the demanded documentation, we had been thriving in gaining our certification.
However these issues are exterior aspects can’t be managed by any company. The a person and only way to stay sustainable is by a structured Production Excellence Solution.
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Our crew of professional regulatory researchers can compose the nonclinical, medical, and CMC sections in CTD and common format for the new drug and biologic apps.
“Kellerman Consulting was professional, successful, and proceeds to point out their help and assistance even after the GMP audit”.
Our Operational Excellence in Producing approach will help organizations to overcome worries by creating and deploying leading-tier small business competencies. As a lean production here advisor, we Enjoy a pivotal purpose in productive organization transformations.
Companies Solutions EY assists clients create prolonged-phrase benefit for all stakeholders. Enabled by facts and technologies, our services and alternatives present trust via assurance and help purchasers remodel, improve and run. Technique by EY-Parthenon
Not only did our audit score reflect how fantastic their process performs, but I also received so a great deal more comprehension of SQF and self confidence as a top quality Manager!”
On ask for, the respective regulatory authority will conduct an on-web site inspection to validate compliance with nationwide legislation and EU GMP necessities.
We will fulfill clinical contracted and direct use resource placement requirements in a variety of roles and features like,
Our Top quality process make certain that our customers acquire personalized stories with locations most related for their functions.
Our pharma consultants know how to partner with executive, authorized, and conversation groups. Every RCA pharma consulting Professional will build a response that can be recognized with the regulatory company and become reasonable to execute.
They are really read more a enjoyment to work with. I have lots to perform and am very fast paced – they outlined almost everything out in a very fair style and received The work done within the precision and element we would have liked it to be. I'd personally operate with them once more!