The purpose of provider qualification is, about the 1 hand, to safeguard provide chains through the products lifecycle and, Alternatively, to be sure sturdy inside procedures in compliance Along with the suitable regulatory necessities.
We comprehend the assorted difficulties and issues you facial area on your own method to acquiring GMP compliance from the pharmaceutical, biotechnology, ATMP and health care system production industries - and we acquire realistic, achievable and cost-productive options for yourself.
KNORS workforce of pharma industry experts rationally style quality management programs and aid to carry out via trainings.
Our interim professionals are incredibly versatile, and their get the job done is billed on hourly foundation only. A set price offer you such as all incidentals can be submitted on Distinctive ask for.
Consulting services: Our consultant will Assess your unique case and offer you an authority assessment.
“Kellerman Consulting was Expert, successful, and proceeds to indicate their assist and guidance even after the GMP audit”.
“Larsen Packaging Items is appreciative to Kellerman Consulting and our Get hold of Tim Grady for aiding us in getting our GMP certification. Tim walked this journey with us from beginning to end and was generally available to solution any concerns and website assist us in acquiring procedures, varieties, etc.
Layout, design, and commercialization of cleanroom amenities are highly-priced procedures that have to have specific organizing and methods. It also dictates the quality and compliance of products which are to get made as well as their profitability in excess of the long term.
The best way to style an air managing process meeting the necessities of space cleanliness classification and environmental security?
This and the precise description of the necessities and procedures permits the enough adaption with the equipment to the true need of your respective GMP method.
As the industry grows even larger and aggressive, the war for excellent expertise is getting momentum. This calls for Specialist get more info know-how in determining, sourcing and fascinating potential-All set talent.
Our Good quality procedure be sure that our clients receive personalised stories with regions most appropriate to their operations.
Do you want aid or suggestions on provider qualification? Make contact with us and convey to us about your necessities. Collectively we find the absolute best Option.
With over twenty years of practical experience with FDA, Wellness Canada, EU and international regulatory businesses worldwide, Regulatory Compliance Associates® presents foremost pharmaceutical consultants. We’re among the list of few pharma consulting organizations that will help you navigate the troubles connected with industry rules.