The goal of supplier qualification is, around the just one hand, to safeguard offer chains all over the products lifecycle and, Conversely, to ensure strong inner procedures in compliance Using the applicable regulatory needs.
“We partnered with Kellerman Consulting pretty early on during the SQF certification system, and by counting on their know-how and methodical approach to amassing, compiling, and Arranging the essential documentation, we had been profitable in gaining our certification.
Nearly all of our pure experts and engineers are familiar with remaining in administration positions and, if demanded, also inside your organization.
Concerned your excellent technique doesn't reflect FDA expectations? Link with previous FDA and marketplace pros that have comprehensive understanding of FDA's recent inspection tactics and anticipations that go beyond the words of regulation.
Our pharmaceutical consulting Professionals will develop a custom-made solution based on your product and firm’s specific requirements. Our regulatory compliance purchasers incorporate:
How do we get it done? By Doing the job carefully with the team and by subsequent our repeatable and trusted course of action.
Commissioning, Qualification & Validation We perform with our clients to create scalable useful resource options to guidance validation attempts through the project lifecycle. Whether it's drafting protocols to execution and compilation of knowledge packs, our means have you covered.
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Zero Breakdown: Maintenance is centered on Performing for the website ultimate objective with a winning servicing method.
R & D Provides intellectual home and regulatory steerage to create a sustainable, compliant design to produce price.
We read more now have accomplished more than seven-hundred+ Vendor/Supplier Qualification audits. Locally primarily based consultants in wider geography so productive high-quality of labor devoid of language barrier and journey constraints.
A GMP advisor supplies the skilled steerage needed to navigate the complexities of GMP compliance. Their considerable understanding of area and Worldwide regulations, market greatest tactics, and the most up-to-date updates in the field equips your Group Using the instruments to meet and exceed regulatory standards.
Our integrated consulting strategy might also deliver both program- and review-amount method such as sensible asset valuation. Learn more about our capabilities in: