Do you need help or suggestions on one or more of those topics? Our knowledgeable industry experts will speed up the entry of your merchandise into your pharmaceutical/biotech current market.
We have an understanding of the assorted problems and problems you confront on the method to attaining GMP compliance while in the pharmaceutical, biotechnology, ATMP and health-related system producing industries - and we establish useful, achievable and cost-successful remedies for you.
As your companion, we could negotiate the probable assessment minefield of regulatory compliance expert services with insight, hindsight, as well as the very clear benefit of our breadth and depth of knowledge and regulatory compliance consulting. We offer the subsequent pharma consulting regulatory affairs expert services for pharmaceutical corporations.
Regulatory Compliance Associates pharma regulatory consultants will create an extensive proof ebook of documented proof demonstrating the corrective action taken to remediate non-compliant challenges.
Our pharmaceutical consulting Experts will create a custom made method based upon your product and enterprise’s particular person wants. Our regulatory compliance consumers contain:
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“Larsen Packaging check here Items is appreciative to Kellerman Consulting and our contact Tim Grady for helping us in obtaining our GMP certification. Tim walked this journey with us from starting to close and was often accessible to get more info solution any concerns and support us in developing strategies, types, and many others.
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Not merely did our audit rating reflect how fantastic their program is effective, but I also gained so a lot more idea of SQF and self-assurance as a Quality Manager!”
Our outcomes-driven team will publish and apply your GMP application, educate you and stay with you until you pass your GMP certification audit.
ADAMAS’s Excellent Manufacturing Exercise (GMP) experts can work to evaluate units at your pharmaceutical, biotechnology, or clinical product Firm or at your vendor sites to find out if the units in position are ample to fulfill your producing requires and the current regulatory benchmarks.
As an extension within your GMP Auditing crew, we’re ready to carry out audits on the behalf, using your recognized audit plan or even the ADAMAS method, whichever will work most effective for your needs.
Do you need help or information on provider qualification? Speak to us and convey to us about your prerequisites. With each other we discover the best possible Answer.
We build custom jobs in compliance with FDA / USDA regulatory specifications and GMP certification necessities For each and every business we serve.