GMP consultancy Secrets
GMP consultancy Secrets
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“Kellerman Consulting acted as a coach for our new QC employ, so we benefited from that and also the successful preparing for your SQF audit. We bought a 98% within the audit. That ought to converse for alone.
Also, each Regulatory Compliance Associates pharma consulting Skilled understands compliance enforcement. We’ll prepare a comprehensive pharma consulting technique to guide in the remediation initiatives, generate constant advancement, and maintain regulatory compliance with the laws.
Custom-made products and services for every method, with personalized procedures designed to meet up with very distinct desires. We’ve discovered a good deal about what operates and what doesn’t. Browse the latest learnings and insights from our clinical advancement experts.
Doing work through the Original development action stage, applicant choice, through scale up and complex transfer in the manufacturing unit community, our skills in validation and microbial evaluation of the manufacturing procedure, hazard assessments and scientific trial designs is often priceless when applied to your portfolio.
Our pharmaceutical consulting Experts will make a custom-made strategy depending on your product and business’s person requires. Our regulatory compliance consumers include things like:
As your partners, Regulatory Compliance Associates can negotiate the probable minefield of regulatory compliance and regulatory research with Perception, hindsight, as well as clear advantage of our unique abilities and knowledge.
From R&D to supply chain and functions to each aspect of commercialization, pharma and biotech firms really need to execute flawlessly across all Proportions should they hope to get.
scarce diseasecell & gene therapyoncology & hematologydermatologymedtechneurosciencepediatricsanalgesiawomen’s health Primary the way in which
We have now an A score with BRCGS and I attribute that to Brian Kellerman and Kellerman Consulting for all the things they have got performed to assist our company to find the certification. Their Preliminary assessment of our corporation, the documents, and knowledge offered to produce our
Zero Breakdown: Maintenance is centered on Performing for the ultimate purpose using a successful maintenance method.
- We ensure that your plant internet site fulfills your company objectives even though becoming completely compliant with the latest Excellent Production Observe rules and standards.
As an extension within your GMP Auditing crew, we’re in the position to perform audits on your own behalf, utilizing your established audit software or perhaps the ADAMAS process, whichever operates very best for your needs.
You can Fee us with the complete conception and document development in your QMS website or have our industry experts accompany or put into practice the processing of unique focal points.
Our professionals prepare all big regulatory get more info submissions and provide considerable top quality Command evaluate for all demo-similar documentation, which include: