The 2-Minute Rule for pharma consultants
The 2-Minute Rule for pharma consultants
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Laura with Kellerman Consulting is just great. She is very helpful, easy to work with and got us by our GMP audit which has a a lot better score than we anticipated. Also, the Corporation of all the documents Kellerman Consulting presented us with is superb.
Foods suppliers have to meet hygiene and GMP restrictions to be certain product or service safety. GMP serves as a Basis for larger security administration units like HACCP and ISO 22000.
We perform along with you to build probably the most ideal formulation based upon the physicochemical and biopharmaceutics Qualities of the molecule.
Attract on our comprehensive subject matter expertise for the shortlist of candidates screened to fit your needs.
that were significant on the profitable completion of this method. I would very suggest Kellerman Consulting for just about any of one's consulting needs as they had been really Qualified and ensured that all items had been addressed prior to our audit. “
Also, Each individual Regulatory Compliance Associates pharma consulting Expert understands compliance enforcement. We’ll get ready a comprehensive pharma consulting technique to aid in the remediation attempts, push continuous advancement, and keep regulatory compliance While using the laws.
For anyone who is now an established organization, you might require help with recovering from non-compliance concerns ensuing from an audit or assist with designing a different GMP facility. We can even supply again-fill employees to include periods of absence or resource shortfalls on initiatives.
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Whether or not You'll need a devoted GMP advisor, sparring lover or enable locating the ideal Option for your personal method, we possess the know-how and expertise to optimize your operations.
With our tested simplified solution, we will do all grunt is effective and ensure you one hundred% ISO typical compliance with least documentation.
Producing processes are tracked and any advancements are calculated. Modifications which have an impact on the drug's consistency and high-quality are deemed needed.
Proprietary expertise array of former FDA and business pros amplified by a corporate tradition of responsiveness and execution. About Overview
Involved your quality process won't reflect FDA expectations? Connect with former FDA and business specialists which have in depth expertise in FDA's present inspection strategies and anticipations website that go beyond the text of regulation.
Our high quality, production, CAPA, and supplier high-quality industry experts conduct complete method testimonials and analyses to website be sure all compliance gaps are closed no matter where by They might be.