Whether or not you’re within the product or service scheduling, development or pharmaceutical lifecycle administration phase or need a remediation method for just a compliance disaster, Regulatory Compliance Associates will information you through every single pharmaceutical consulting step of the regulatory method.
Go your Firm ahead although retaining a continuous and total condition of regulatory compliance. From regulatory observation responses to inspection readiness, our substantial team of compliance specialists can deal with practically any regulatory obstacle.
Nevertheless these difficulties are external variables can’t be controlled by any company. The one and only way to remain sustainable is by a structured Manufacturing Excellence Solution.
The founding partners, whose individual biodata are supplied on the web site separately, have a solid motivation to Integrity, High quality and Excellence and function with their shoppers to realize the consumer’s aims with complete compliance and rigid adherence to the very best ethical requirements in a very time certain style. We Dwell upto our mentioned motto "Practical experience, Skills, EXCELLENCE" in all our consulting engagements.
Our team of experienced regulatory scientists can produce the nonclinical, scientific, and CMC sections in CTD and classic format for your personal new drug and biologic programs.
We comprehend the complexities of operating a everyday living science organization and possess areas of expertise that include just about every side of R&D, functions, regulatory affairs, high-quality, and production.
From R&D to produce chain and operations to each aspect of commercialization, pharma and biotech providers should execute flawlessly across all dimensions if they hope to get.
Alex has held administration stage roles in Excellent Assurance, guaranteeing product high quality & regulatory compliance, and Senior Technical Manager positions accountable for CMO management, oversight and tech-transfer of pharmaceutical products and solutions. This expertise equips him perfectly in evaluating production systems for early phase products and solutions, together with late phase and business items for EU and US marketplaces.
I really advise working with Kellerman Consulting. Dealing more info with Brian Kellerman place me at relieve. He’s extremely enlightening, affected person, and took the time to stroll me by the procedure. An all around good person! If ever I need the providers this business offers I’ll seem no further more.
Upon request, the respective regulatory authority will perform an on-web-site inspection to verify compliance with national law and EU GMP demands.
Tim and Brian rallied all over me and created absolutely read more sure I was prepared to meet the challenge head on. From writing and examining files, to educating an entire amateur, to undertaking a mock audit upfront, the Kellerman group built positive we were being Prepared don't just to move, but to score a ninety one on our to start with audit. I couldn't propose them far more remarkably”!
With workplaces in three continents, our world-wide capabilities allow ADAMAS to supply coverage for an array of healthcare shoppers, working internationally.
"We attempt to help increase outcomes and develop a more healthy, much more sustainable world for folks all over the place.
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