At Regulatory Compliance Associates, we provide the pharma consulting knowledge and pharma consultants necessary to guide you in the good quality compliance approach.
Our staff of professionals has properly completed several gap analyses in throughout the last 20 years and provides this consulting support for all GMP devices.
IQVIA Decentralized Trials produce function-built scientific products and services and systems that have interaction the proper individuals anywhere They may be. Our hybrid and totally virtual remedies have been utilised in excess of any Other folks.
I might remarkably endorse Kellerman Consulting to any person contemplating this kind of certification for their Corporation”.
“We realized if we needed to get exactly where we wanted to go together with our small business and securing a number of These major shoppers, that we needed to have SQF certification. After i initially started off conversing with Kellerman Consulting, I realized they were industry experts.
Elevate industrial types with precision and pace employing AI-driven analytics and technological innovation that illuminate concealed insights in info.
Selecting a GMP consultant is often a vital determination which can condition your compliance journey and affect the overall success of your small business.
Alex has held management amount roles in High-quality Assurance, guaranteeing products excellent & regulatory compliance, and Senior Technical Supervisor positions responsible for CMO management, oversight and tech-transfer of pharmaceutical goods. This experience equips him well in evaluating production programs for early stage goods, along with late period and professional products for EU and US markets.
With a lot more than twenty years of experience with FDA, Well being Canada, EU and world wide regulatory organizations all over the world, Regulatory Compliance Associates® gives major pharmaceutical consultants. We’re one of many several pharma consulting companies which can help you navigate the challenges affiliated with field restrictions.
Our benefits-driven group website will produce and put into practice your GMP method, prepare you and stick with you right up until you go your GMP certification audit.
Kellerman Consulting does a fantastic occupation of regularly Conference buyers’ anticipations and using time to be aware of the demands in their exceptional client. Their company goes higher than and beyond expectations.
It results in improved get more info sector speed and elevated transparency and accountability throughout a variety of companies involved in formulation (throughout multiple dosage forms), API and biosimilar.
Regulatory Compliance Associates pharma regulatory consultants will build an extensive evidence reserve of documented proof demonstrating the corrective action taken to remediate non-compliant problems.
The restrictions approach bordering pharmaceutical corporations is usually challenging for even quite possibly the most skilled sector veteran to understand. Just one misstep could suggest major and Long lasting effects for your company.