Whether you’re from the merchandise preparing, development or pharmaceutical lifecycle management stage or require a remediation tactic for any compliance crisis, Regulatory Compliance Associates will tutorial you through just about every pharmaceutical consulting phase on the regulatory system.
g. bear in mind configurations), and Efficiency cookies to evaluate the web site's performance and improve your expertise., and Advertising/Concentrating on cookies, which might be set by 3rd parties with whom we execute internet marketing campaigns and allow us to present you with written content pertinent for you.
With a mixed tenure throughout our corporations of just about 200 yrs and our business-acknowledged scientific and technological expertise, we support to ensure the basic safety of around 190 million clients and Health care practitioners throughout the world each and every year.
Competitors force each perceived gain. The stakes are superior, however the remedies are in this article. We equip you Using the resources and experience to outperform the Opposition, increase your earnings and get continuously.
Our group of knowledgeable regulatory researchers can generate the nonclinical, medical, and CMC sections in CTD and regular format for your personal new drug and biologic apps.
The outcomes of files and on-web-site checks are documented and also the observations and identified deviations concerning GMP specifications are talked about.
which were essential on the thriving completion of this method. I would extremely recommend Kellerman Consulting for any of the consulting demands as they were being very Qualified and ensured that every one goods ended up addressed before our audit. “
Regulatory affairs is Regulatory Compliance Associates spine. We exceed other pharma consulting businesses with field authorities seasoned in complexities of the pharmaceutical and biopharmaceutical industries.
Now we have an A ranking with BRCGS And that i attribute that to Brian Kellerman and Kellerman Consulting for anything they've got performed that will help our small business to obtain the certification. Their initial evaluation of our firm, the paperwork, and information delivered to make our
Our industry experts performs third party evaluation and gap Evaluation which has a quantified Instrument to evaluate the company’s condition of regulatory compliance. We help the businesses in coming up with CAPA for deficiencies elevated by regulatory inspections.
We can easily satisfy scientific contracted and immediate hire source placement desires in many different roles and functions which include,
As your associate, we can negotiate the opportunity evaluation minefield of regulatory compliance services with Perception, hindsight, along with the obvious benefit of our breadth and depth of knowledge and regulatory compliance consulting. We provide the next pharma check here consulting regulatory affairs services for pharmaceutical providers.
You may attain the same read more 100% results rate regardless of which of our workforce users you work with. You may receive a foods security & high quality roadmap for getting your product or service Licensed.
We create tailor made initiatives in compliance with FDA / USDA regulatory needs and GMP certification demands for every organization we serve.