“Kellerman Consulting acted as being a trainer for our new QC employ, so we benefited from that and also the productive planning for that SQF audit. We acquired a 98% about the audit. That should talk for itself.
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As your spouse, we could negotiate the possible evaluation minefield of regulatory compliance providers with insight, hindsight, and also the very clear advantage of our breadth and depth of knowledge and regulatory compliance consulting. We offer the following pharma consulting regulatory affairs products and services for pharmaceutical firms.
Therefore, all supplier qualification steps add to the general plans of medicinal item basic safety, efficiency and compliance.
GMP Specialist comprehends your item and programs the power in accordance with Global regulatory specifications.
Christina Sanchez Miller, MPH has about twenty years of management, biologics, top quality assurance and exploration knowledge during the medical subject. She's a broadcast creator in scientific textbooks, papers and has offered at numerous Intercontinental conferences.
No matter whether you’re in the product or service planning, enhancement or pharmaceutical lifecycle management stage or require a remediation technique to click here get a compliance crisis, Regulatory Compliance Associates will guideline you thru just about every pharmaceutical consulting phase on the regulatory process.
This is often triggering an influence change with new entrants (usually not pushed by gain) disrupting the incumbents.
I very endorse dealing with Kellerman Consulting. get more info Dealing with Brian Kellerman place me at simplicity. He’s incredibly informative, affected individual, and took the time to walk me by the procedure. An throughout great male! If ever I need the solutions this enterprise provides I’ll appear no more.
- We be certain that your plant web page meets your online business goals when being fully compliant with the newest Great Producing Practice laws and standards.
Most FDA GMP consultants will have GMP consulting knowledge which is a vital qualification since they have got experienced options to operate with quite a few organizations and in numerous configurations. The significance of operational practical experience, having said that, really should not be missed.
With workplaces in 3 continents, our international capabilities permit ADAMAS to offer coverage for a wide range of Health care customers, operating internationally.
By way of mock inspections we’ll Look at that all is accurately, and focus on remediation as needed.
Tell us about your consulting requirements and have the conversation started. Notify us about your unique demands or just indicate that you'd like a phone-again to discuss your undertaking. We will adhere to up in 1 business working day.