Kellerman Consulting arrived towards the rescue for me soon after working with An additional competitor who still left me in the dead of night. I used to be so relieved to find a liable, professional consulting firm who could assist a brand new operator out in developing a complete blown HACCP strategy - and train me along the way!
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As a result of our extensive team of consultants, we usually are capable to execute the requested Hole Examination in a timely method.
We realize the complexities of running a lifestyle science company and possess parts of experience which include each individual facet of R&D, operations, regulatory affairs, excellent, and production.
Our pharmaceutical consulting Authorities will make a tailored approach according to your product and organization’s specific requirements. Our regulatory compliance consumers involve:
“Kellerman Consulting was professional, successful, and continues to indicate their assist and advice even following the GMP audit”.
From R&D to produce chain and operations to each aspect of commercialization, pharma and biotech corporations need to execute flawlessly across all Proportions whenever they hope to get.
Confident supply chain with qualified suppliers and robust processes is finally the basis for cutting down grievances and making certain medicinal product or service security.
Creating on a loaded historical past of creating AI for Health care, IQVIA AI connects the ideal information, technological know-how, and experience to address the unique needs of healthcare. It is what we simply call Health care-grade AI.
Our GMP/GxP gurus hold you within the Harmless aspect. We provide Qualified support in the implementation of GxP-compliant good quality management devices.
Laura with Kellerman Consulting is just terrific. She is rather valuable, uncomplicated to work with and got us by way of our GMP audit having a a lot better score than we expected. Also, the Business of many of the files Kellerman Consulting delivered us with is superb.
The conventional scope of the structure critique could vary from viewing an individual home or an entire facility. Besides GMP compliance the output capability and consumers products spectrum Perform a read more substantial role within the evaluation approach.
Great Producing click here Tactics (GMPs) are known as prerequisite courses, or foods security and excellent fundamentals. They're the positioning and firm certain policies and each day functions set into location to hold solutions safe. GMPs may very well be created down or communicated verbally and are normally enforced by way of High quality Assurance or administration staff.
We generate custom tasks in compliance with FDA / USDA regulatory requirements and GMP certification prerequisites For each and every business enterprise we provide.