We obtained via our audit and we are quite proud to own received a 99.37% score. I have been working For most, a few years and it is extremely refreshing to operate with somebody which might be so professional and do the things they say they're going to do and even now address those with kindness.
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Due to our intensive group of consultants, we are generally ready to execute the requested Hole Evaluation inside a timely manner.
The rules course of action bordering pharmaceutical providers might be challenging for even the most seasoned business veteran to grasp. Only one misstep could suggest significant and Long lasting implications for your organization.
Qualification of premises, facilities and machines and also the planning with the corresponding documentation
As your companions, Regulatory Compliance Associates can negotiate the potential minefield of regulatory compliance website and regulatory due diligence with insight, hindsight, plus the apparent benefit of our exceptional know-how and expertise.
This working experience authorized Ana to realize an in-depth comprehension of the regulatory authorities’ expectations and a comprehensive familiarity with the EU and US GMP rules. She’s also carried out GMP inspections to read more third party nations on EMA’s behalf.
Global source chain disruption and API scarcity will force the marketplace to diversify sourcing locations and build new provider networks – all whilst giving authentic-time, whole-merchandise visibility and traceability.
Does one currently Have got a requirement and need to fill a leadership situation on an interim basis? Inquire us about suited profiles in your short-term vacancy.
Our GMP/GxP authorities preserve you to the Protected facet. We provide Skilled assist during the implementation of GxP-compliant quality management techniques.
Kellerman Consulting does an awesome task of continually meeting prospects’ expectations and getting time to know the wants of their one of a kind shopper. Their company goes over and over and above anticipations.
What kind of assist you involve: Our GMP consultants will manual you thru the whole process of acquiring your production authorization and also the corresponding GMP certification.
- The audit report shall be then obtainable inside our Audit report database which can be available to any of your respective consumers. We will attain authorization from the provider just before sharing experiences towards the customers.
“They are really so Experienced and it had been just an actual satisfaction working by way of anything. I'd personally Unquestionably endorse Kellerman Consulting. I already have. When individuals check with me with regard to the SQF consulting method, I would not hesitate to mention," undoubtedly contact Kellerman Consulting'' ” .