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Our crew of professionals has properly performed many gap analyses in throughout the last 20 years and gives this consulting support for all GMP systems.

As your lover, we will negotiate the likely evaluation minefield of regulatory compliance services with Perception, hindsight, plus the crystal clear advantage of our breadth and depth of knowledge and regulatory compliance consulting. We provide the subsequent pharma consulting regulatory affairs providers for pharmaceutical organizations.

Kellerman Consulting’s GMP consultants supply a written high quality & foods protection guide that is definitely customized towards your products, course of action and Procedure. We offer quality consulting and foodstuff protection instruction In line with present FDA regulatory needs and customized towards the GMP certification scheme that you will be wishing to get certified in opposition to.

At Regulatory Compliance Associates, we offer the pharma consulting expertise and pharma consultants required to tutorial you throughout the high-quality compliance approach.

Discover consultant CVs » Begin a guide look for » Be part of our consulting workforce. With the FDA Team, we've been constantly searching for leading talent to increase our network. If you're able to deliver experience and new perspectives to our consulting team, we invite you to send us your resume.

which were vital towards the profitable completion of this method. I would extremely suggest Kellerman Consulting for virtually any get more info of your consulting read more requirements since they ended up really Experienced and ensured that each one items had been addressed just before our audit. “

Alex has held management level roles in High-quality Assurance, ensuring merchandise top quality & regulatory compliance, and Senior Technological Supervisor positions chargeable for CMO management, oversight and tech-transfer of pharmaceutical solutions. This experience equips him properly in analyzing producing programs for early period products, as well as late phase and professional products and solutions for EU and US markets.

With a lot more than twenty years of experience with FDA, Well being copyright, EU and world regulatory companies around the globe, Regulatory Compliance Associates® gives primary pharmaceutical consultants. We’re among the list of several pharma consulting corporations that can help you navigate the challenges affiliated with market laws.

Moreover, Each and every Regulatory Compliance Associates pharma consulting Specialist understands compliance enforcement. We’ll put together an extensive pharma consulting technique to help with your remediation endeavours, push continuous advancement, and manage regulatory compliance Along with the restrictions.

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Combining extremely educated experts and thoroughly refined procedures with our world-class technological know-how.

Will need to create or augment your Good quality Assurance crew with leading expertise? We assist 1000s of life science corporations outsource their QA initiatives and fill specialised roles by way of handy staff augmentation and recruitment.

We enable probably the most innovative organizations completely transform life-switching Strategies and breakthrough science into new clinical therapies.