“Kellerman Consulting acted for a coach for our new QC seek the services of, so we benefited from that as well as the prosperous preparation for the SQF audit. We obtained a 98% around the audit. That ought to converse for alone.
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KNORS workforce of pharma pros rationally structure quality management units and assist to apply by trainings.
At Regulatory Compliance Associates, we provide the pharma consulting working experience and pharma consultants required to guideline you through the high-quality compliance course of action.
Qualification of premises, facilities and devices in addition to the preparing of your corresponding documentation
As your partners, Regulatory Compliance Associates can negotiate the possible minefield of regulatory compliance and regulatory due diligence with insight, hindsight, as well as the crystal clear advantage of our unique expertise and encounter.
The pharmaceutical discipline is stuffed with private information, from patient data to trial outcomes to patented work; it is completely important to protect this knowledge and IP from any cybersecurity danger.
Alex has held management amount roles in Excellent Assurance, making certain merchandise quality & regulatory compliance, and also Senior Technical Manager positions accountable for CMO management, oversight and tech-transfer of pharmaceutical products and solutions. This expertise equips him very well in analyzing producing devices for early stage products, pharma consultancy along with late stage and commercial merchandise for EU and US marketplaces.
We can hence offer you this consulting company in Each and every method normal available in the market. The look evaluation can generally be completed without a corresponding on-internet site presence, entirely based on the technological documentation about the general and comprehensive organizing of an installation.
Our complete-time GMP consultants react straight away to all shopper concerns, which demonstrates among our Main values.
EY refers to the worldwide Group, and should confer with a number of, with the member corporations of Ernst & Young Global Limited, Just about every of which happens to be a independent lawful entity.
We’re scientific enhancement specialists centered on aiding currently’s most revolutionary biotech and specialty pharma firms acquire their most effective ideas from benchtop to bedside.
A GMP advisor gives get more info the pro direction necessary to navigate the complexities of GMP compliance. Their extensive expertise in community and international restrictions, market greatest methods, and the newest updates in the field equips your Group Along with the instruments to fulfill and exceed regulatory criteria.
Our pharma consultants know how to spouse with executive, authorized, and communication groups. Each and every RCA pharma consulting Specialist will create a response that will be accepted from the regulatory agency and be real looking to execute.