GMP consultants No Further a Mystery
GMP consultants No Further a Mystery
Blog Article
“Kellerman Consulting acted like a trainer for our new QC employ, so we benefited from that together with the successful planning to the SQF audit. We acquired a 98% within the audit. That should discuss for alone.
We fully grasp the varied issues and difficulties you face on the strategy to obtaining GMP compliance during the pharmaceutical, biotechnology, ATMP and health care machine producing industries - and we create functional, achievable and cost-powerful remedies to suit your needs.
- And when on-web page visits will not be feasible, our flexible shipping design permits us to guarantee business enterprise continuity and the lowest doable effect on all auditing functions, we carry out audits remotely via documentation evaluations and SME discussions According to Pharmexpert methodology. And When onsite audit feasible, We approach for onsite audit.
To start the Regulatory Compliance Associates scoping system today, please enter your details from the blue sort underneath and click on the submit button at The underside on the webpage.
At Regulatory Compliance Associates, we provide the pharma consulting expertise and pharma consultants required to guidebook you with the excellent compliance course of action.
Regulatory affairs is Regulatory Compliance Associates spine. We exceed more info other pharma consulting corporations with marketplace specialists skilled in complexities in the pharmaceutical and biopharmaceutical industries.
Regardless of whether you’re in the products arranging, growth or pharmaceutical lifecycle management phase or need a remediation technique for your compliance disaster, Regulatory Compliance Associates will guidebook you thru just about every pharmaceutical consulting action in the regulatory method.
Confident source get more info chain with capable suppliers and sturdy processes is eventually the basis for lessening complaints and making sure medicinal solution security.
Produce and disseminate evidence that solutions critical clinical, regulatory and industrial issues, enabling you to travel smarter choices and meet up with your stakeholder wants with assurance.
Developing IQVIA’s positions on critical tendencies in the pharma and life sciences industries, which has a deal with EMEA.
Tim and Brian rallied about me and built confident I had been ready to meet up with the obstacle head on. From creating and examining files, to educating an entire newbie, to accomplishing a mock audit beforehand, the Kellerman group produced sure we have been ready not simply to pass, but to score a 91 on our first audit. I could not advise them additional really”!
We've got accomplished much more than seven-hundred+ Seller/Supplier Qualification audits. Domestically primarily based consultants in wider geography so successful high-quality of work without having language barrier and journey constraints.
Regulatory Compliance Associates pharma regulatory consultants will produce a comprehensive proof reserve of documented evidence demonstrating the corrective action taken to remediate non-compliant difficulties.
We develop custom made jobs in compliance with FDA / USDA regulatory prerequisites and GMP certification demands for every business we provide.