Get qualified help at every single stage from the product lifecycle. We assistance lifetime science corporations speedily entry the industry's very best consultants, contractors, and candidates. Our methods assist in every single stage of your solution lifecycle.
You take pleasure in the assist of GMP consultants who evaluation every single venture like a staff. The co-founders of Kellerman Consulting are involved with each project at every phase to be sure that we've been providing on our commitment to our shoppers.
Whether you are starting from scratch, otherwise you’d like us to incorporate your present packages, we’ll publish the program you should get certified.
Anxious your excellent program will not mirror FDA expectations? Link with previous FDA and field professionals who definitely have in depth knowledge of FDA's recent inspection tactics and anticipations that transcend the text of regulation.
Prior to this, an suitable quality administration procedure have to are already set up, which demonstrates suited actions to be sure the right top quality and protection of your medicinal items As outlined by EU expectations.
Unparalleled know-how: Our consultants have large marketplace practical experience and an insider’s standpoint from their time as GMP inspectors. They have got stood on both sides from the GMP compliance equation, delivering them with a novel knowing that informs every provider we offer.
Regulatory affairs is Regulatory Compliance Associates backbone. We exceed other pharma consulting businesses with market gurus experienced in complexities in the pharmaceutical and biopharmaceutical industries.
Firms getting a affected individual-centered strategy are far better equipped to determine personalized connections for his or her patients and meaningfully engage with them through the click here complete remedy journey.
Experienced dozens of pharmaceutical executives and leaders regarding how to effectively and compliantly use The brand new digital Resource to streamline workflows and vital procedures
On request, the respective regulatory authority will perform an on-web site inspection to confirm compliance with national legislation and EU GMP needs.
As the market grows greater and competitive, the war for quality expertise is getting momentum. This calls for Experienced abilities in identifying, sourcing and fascinating future-All set talent.
We have accomplished much more than seven-hundred+ Vendor/Supplier Qualification audits. Regionally dependent consultants in broader geography so productive top quality of work with no language barrier and vacation limits.
Regulatory Compliance Associates pharma regulatory consultants will build an extensive proof e book of documented evidence demonstrating the corrective action taken to remediate non-compliant difficulties.
We're going to more info compose your supplier acceptance application, perform together with you to definitely employ it, and practice you to help keep it running.