Numerous providers decide to use consultants to deliver company guidance expert services to thoroughly get ready for certification audits . Kellerman Consulting will publish & carry out meals safety and high-quality plans which have been customized for your product or service and process.
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Legislation firms in search of pharmaceutical consulting agency know-how in the remediation of warning letters, consent decrees, 483’s or import bans
We realize the complexities of working a existence science small business and have locations of expertise which include every single side of R&D, operations, regulatory affairs, top quality, and production.
Therefore, these things to do have to be prepared in detail While using the conclusion in your mind, including the regulatory, project funding, the future expansion for the types of products and solutions In keeping with intended industrial marketplaces in addition to the power’s region of area.
You are going to receive project management providers and We'll stay with you right until you go your audit – regardless of the.
We're capable of not just comprehension these world-wide rules, but will also of providing strategic methods that take into account equally world-wide and native compliance demands.
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Kellerman Consulting has supported hundreds of clients nationwide to correctly move their regulatory inspections and click here their GMP and cGMP certification audits.
We support web-site for efficiently passing inspections and style and design submit-inspections remediation programs to ascertain & improve GMP compliance and keep acceptance in your solution with Pharmexpert's tailor-made and value-helpful plans for Good quality Administration for Pharmaceuticals, Bio-Pharma and MD.
Our International Existence Sciences sector may help you navigate forward and achieve sustainable results in The brand new well being-outcomes-pushed ecosystem.
As your partner, we will negotiate the likely evaluation minefield of regulatory compliance solutions with insight, hindsight, as well as the crystal clear advantage of our breadth and depth of data and regulatory compliance click here consulting. We provide the following pharma consulting regulatory affairs expert services for pharmaceutical organizations.
Need to construct or augment your High-quality Assurance team with prime expertise? We help Many life science businesses outsource their QA initiatives and fill specialised roles via handy staff augmentation and recruitment.
Convey to us regarding your consulting needs and acquire the conversation began. Explain to us regarding your specific requires or simply reveal that you want a simply call-again to discuss your project. We'll stick to up in a person business working day.