We supplies turnkey good quality options and concentrates on featuring exceptional Price effectiveness, while keeping maximum quality standards for our Purchasers.
We are going to critique your documentation and check out your facility, detect gaps in your present system and facility functions, and we will assist you to fill Individuals gaps to be able to pass your audit.
Law corporations looking for pharmaceutical consulting agency expertise while in the remediation of warning letters, consent decrees, 483’s or import bans
An in-focus investigate The nice Production Practice (GMP) audit entire world And the way the thought of remote or virtual audits, a fairly new thought is being adopted.
GMP consultants don't just aid keep compliance, but they also identify likely regions of danger in advance of they develop into substantial troubles.
This can be what a normal procedure appears like: The GMP consultant initial checks the corporate-distinct documentation and produces a gap Examination strategy. Dependant on this hole Investigation system, the Examination on-web-site will probably be performed.
No matter if you’re while in the item scheduling, development or pharmaceutical lifecycle management phase or need a remediation system to get a compliance disaster, Regulatory Compliance Associates will manual you thru each pharmaceutical consulting action of your regulatory approach.
Alex has held administration level roles in Top quality Assurance, making sure solution high quality & regulatory compliance, along with Senior Technical Manager positions chargeable for CMO administration, oversight and tech-transfer of pharmaceutical goods. This expertise equips him nicely in analyzing manufacturing devices for early phase items, and late phase and industrial items for EU and US marketplaces.
We try to help boost outcomes and create a much healthier, additional sustainable environment for men and women almost everywhere.
Zero get more info Breakdown: Upkeep is focused on Functioning for the ultimate aim with a profitable maintenance method.
Tim and Brian rallied all around me and manufactured confident I used to be willing to satisfy GMP consultants the obstacle head on. From writing and reviewing documents, to educating an entire amateur, to undertaking a mock audit beforehand, the Kellerman staff made confident we have been Completely ready not only to move, but to attain a 91 on our 1st audit. I couldn't propose them more very”!
We've got concluded greater than seven-hundred+ Seller/Provider Qualification audits. Domestically centered consultants in broader geography so successful top quality of labor with out language barrier and vacation limitations.
Regulatory Compliance Associates pharma regulatory consultants will develop a comprehensive proof ebook of documented proof demonstrating the corrective action taken to remediate non-compliant concerns.
We can easily offer GMP providers for specific specialized niche remedies to your issues along with extensive deals that go over all GMP necessities arising from the context of pharmaceutical production things to do.