Kellerman Consulting arrived to the rescue for me right after dealing with A different competitor who remaining me in the dead of night. I had been so relieved to locate a liable, experienced consulting company who could enable a fresh operator out in producing a complete blown HACCP plan - and educate me along the way in which!
We fully grasp the diverse problems and problems you face on your way to achieving GMP compliance inside the pharmaceutical, biotechnology, ATMP and professional medical unit production industries - and we produce sensible, achievable and cost-effective options in your case.
Proprietary expertise collection of former FDA and field industry experts amplified by a corporate society of responsiveness and execution. About Overview
Kellerman Consulting’s GMP consultants provide a published good quality & meals security guide which is customized towards your item, procedure and Procedure. We provide good quality consulting and food items basic safety training In line with existing FDA regulatory requirements and customized on the GMP certification scheme that you will be wishing for getting Licensed from.
Qualification of premises, facilities and products in addition to the preparing with the corresponding documentation
Unparalleled know-how: Our consultants have large sector encounter and an insider’s perspective from their time as GMP inspectors. They've got stood on both sides in the GMP compliance equation, offering them with a unique knowing that informs each and every services we provide.
The sequence of the tools are customised According to consumer’s enterprise requirement and discomfort factors.Tetrahedron 1st conducts an comprehensive audit/observation of current Procedure in advance of planning the implementation approach.
Regulation corporations searching for pharmaceutical consulting business experience within the remediation of warning letters, consent decrees, 483’s or import bans
With lean production specialist, businesses and industries can knowledge our sustainable method of scale their business.
Our pharma consultants learn how to lover with government, legal, and interaction groups. Each and every RCA pharma consulting Skilled will website create a response that may be recognized by the regulatory agency and be sensible to execute.
ADAMAS’s Very good Production Observe (GMP) professionals can work To judge units at your pharmaceutical, biotechnology, or health care product Group or at your vendor web pages to determine When the units in place are ample to fulfill your production needs and The present regulatory criteria.
We’re medical development specialists focused on aiding currently’s most ground breaking biotech and specialty pharma providers choose their here finest Tips from benchtop to bedside.
Our Excellent method make certain that our customers receive individualized reviews with places most applicable to their operations.
Clarkston supports late-stage scientific firms on their own route to commercialization. Leveraging deep business know-how and acknowledged functional and company procedure leadership that will help corporations changeover from growth to commercialization, ensuring sustainable, extensive-phrase progress.