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“We partnered with Kellerman Consulting extremely early on within the SQF certification method, and by depending on their skills and methodical method of amassing, compiling, and Arranging the essential documentation, we were being effective in attaining our certification.
The nice GMP consultants may possibly advise modern systems and demonstrated procedures to realize better top quality and more successful processes. Choosing FDA GMP consultants can avoid pricey mistakes For several makers.
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Kellerman Consulting held my hand every single move of how (and have confidence in me I desired it)! Kellerman Consulting acquired me by means of all of my approvals by having an simple to observe HACCP plan that appeased a USDA regional manager.
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Irrespective of whether you’re from the solution arranging, improvement read more or pharmaceutical lifecycle management stage or need a remediation system for your compliance disaster, Regulatory Compliance Associates will information you thru just about every pharmaceutical consulting stage on the regulatory process.
Especially, the next facets need to be documented and ensured: description of the internal processes, the get more info suitability of all premises and amenities, the conformity of elements employed, the qualification in the personnel and the caliber of exterior providers.
Kellerman Consulting has supported countless clientele nationwide to properly pass their regulatory inspections and their GMP and cGMP certification audits.
Our whole-time GMP consultants react straight away to all client concerns, which demonstrates amongst our Main values.
In the event that medicinal solutions shall be produced for a medical demo, a producing authorisation in addition to a corresponding GMP certificate are now expected for this reason.one
Trust in our skills from acquiring served our consumers pass a huge selection of GMP audits. Our GMP consultants will guide your team to achievements.
Need to have to construct or augment your High quality Assurance staff with leading talent? We enable 1000s of life science organizations outsource their QA tasks and fill specialised roles by way of handy staff members augmentation and recruitment.
Forecasting & Franchise Approach Reinforce your portfolio by generating extra informed conclusions and get ready for that impact of recent study discoveries.