- Joining our IGAP method/ Audit report library is free for suppliers/manufacture. Our expert and qualified auditor will perform complete web-site audit of provider covering substantial variety of molecules/items (if not by now executed) without any cost to provider and specific audit report shall be ready.

Our crew of experts has effectively completed many gap analyses in throughout the last twenty years and provides this consulting assistance for all GMP programs.

Legislation companies trying to get pharmaceutical consulting business experience in the remediation of warning letters, consent decrees, 483’s or import bans

We don’t just guarantee your compliance Along with the rules; we equip you With all the understanding and applications to keep up this compliance. Rely on us to deliver useful, exact, and value-successful solutions tailor-made on the distinctive GMP issues your organization faces.

Our workforce of knowledgeable regulatory experts can generate the nonclinical, medical, and CMC sections in CTD and standard format on your new drug and biologic programs.

Provider Qualification The good manufacturing apply setting involves qualification of suppliers to be certain drug high-quality and basic safety

We support corporations through the biotechnology, pharmaceutical and clinical technology fields harness this disruption by forming the best alliances, superior allocating sources and developing belief with consumers.

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Continue to be ahead inside of a speedily changing world. GMP consultants Subscribe to Bain Insights, our month GMP consultants in India to month think about the critical difficulties struggling with world-wide businesses.

Partnering with Other people to share info, medicine and sources although anticipating tendencies and regulatory improvements might help be certain sustainability inside the more and more evidence-based mostly, outcomes-concentrated sector.

Our World wide Daily life Sciences sector will let you navigate ahead and accomplish sustainable accomplishment in the new overall health-results-pushed ecosystem.

The conventional scope of the design and style assessment could vary from viewing one home or an entire facility. Apart from GMP compliance the generation capacity and shoppers product or service spectrum Participate in a substantial job inside the analysis approach.

You may commission us with the thorough conception and doc generation for your QMS or have our professionals accompany or put into practice the processing of particular person focal factors.

“They're so professional and it was just a real pleasure Doing work via every thing. I'd personally Totally endorse Kellerman Consulting. I have already got. When people question me concerning the SQF consulting process, I wouldn't be reluctant to convey," undoubtedly call Kellerman Consulting'' ” .