The best Side of GMP consultancy
The best Side of GMP consultancy
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- Joining our IGAP software/ Audit report library is free for suppliers/manufacture. Our seasoned and skilled auditor will execute total web-site audit of supplier masking big quantity of molecules/solutions (if not currently performed) without any charge to provider and detailed audit report shall be prepared.
All conversations is going to be shut benefits-orientated, and all difficulties are going to be evaluated and documented intimately. As a client, you'll get the report on the dialogue. Presentation of the effects before other company representatives is possible on demand from customers.
Tailored expert services for each plan, with customized processes meant to satisfy very unique wants. We’ve discovered a good deal about what functions and what doesn’t. Search the most up-to-date learnings and insights from our clinical growth professionals.
We don’t just guarantee your compliance Along with the laws; we equip you Using the awareness and resources to take care of this compliance. Rely on us to provide realistic, precise, and value-effective solutions tailor-made on the special GMP challenges your Corporation faces.
Our pharmaceutical consulting Industry experts will create a custom-made method based upon your product and firm’s particular person needs. Our regulatory compliance consumers include things like:
“Kellerman Consulting was Experienced, effective, and carries on to show their support and guidance even once the GMP audit”.
Our Operational Excellence in Producing solution assists corporations to beat issues by establishing and deploying prime-tier business techniques. Being a lean production expert, we Engage in a pivotal position in prosperous business transformations.
Regulation companies looking for pharmaceutical website consulting business know-how while in the remediation of warning letters, consent decrees, 483’s or import bans
We have now an A ranking with BRCGS and I attribute that to Brian Kellerman and Kellerman Consulting for everything they've got finished to assist our business enterprise to obtain the certification. Their Preliminary evaluation of our company, the documents, and information offered to make our
Upon request, the respective regulatory authority will carry out an on-web-site inspection to confirm compliance with nationwide law and EU GMP demands.
As the market grows more substantial and aggressive, the war for excellent expertise is gaining momentum. This calls for Qualified expertise in determining, sourcing and engaging long term-All set expertise.
All of our full-time GMP website consultants are very well-versed in Kellerman Consulting’s repeatable and reputable approach. Our crew’s collaborative lifestyle offers you the good thing about our collective working experience with numerous thriving results.
cGMP is a action-up from GMP criteria and is required for dietary nutritional supplement producers. cGMP implies Latest Good Producing Practice. cGMP laws demand additional solution tests and even more thorough high-quality management methods in position.
We are going to produce your supplier approval system, operate together with you to definitely employ it, and educate you to help keep it managing.