The aim of supplier qualification is, about the 1 hand, to safeguard source chains all through the item lifecycle and, Then again, to ensure strong interior processes in compliance Using the pertinent regulatory requirements.
We'll evaluation your documentation and visit your facility, discover gaps within your present software and facility functions, and we can assist you fill Those people gaps in an effort to pass your audit.
GMP consultants with QA experience understand how Just about every Office during the Firm interacts While using the manufacturing procedures and methods. QA specialists have a whole image in your mind when coming up with a high quality management method and therefore are incredibly experienced in federal, nearby, and Expert specifications.
It’s a pharma consultancy Started by regulatory compliance executives within the pharmaceutical marketplace. Just about every pharmaceutical business guide around the Regulatory Compliance Associates workforce is aware the unique inner workings of the regulatory procedure.
Customized options: No two organizations are a similar, and we regard these differences by tailoring our consulting providers to the Business’s exceptional desires, conditions, and challenges. We provide bespoke methods meant to tackle your distinct GMP compliance hurdles head-on.
“Kellerman Consulting was Expert, efficient, and continues to show their help and guidance even once the GMP audit”.
Commissioning, Qualification & Validation We get the job done with our consumers to produce scalable resource ideas to aid validation attempts all over the venture lifecycle. Whether it's drafting protocols to execution and compilation of information packs, our assets have you covered.
With much more than 20 years of knowledge with FDA, Overall health Canada, EU and global regulatory businesses around the globe, Regulatory Compliance Associates® delivers leading pharmaceutical consultants. We’re one of the couple pharma consulting firms which will help you navigate the worries affiliated with marketplace polices.
Not just did our read more audit rating replicate how wonderful their program functions, but I also received so far more knowledge of SQF and self confidence as a top quality Manager!”
"Its an extended proven indisputable fact that a reader are going to be distracted by the readable written content of a web site when"We're pleased to inform that a person extremely expert." For virtually any requirement about on-website, compose to us at [email protected] OR CALL AT 9878880408
Inside of Valicare GmbH and thru the solid cooperation with our mum or dad company Syntegon detailed competencies about classical pharmaceutical and biotechnological output strains also for Superior therapy medicinal products and solutions and Exclusive pharmaceutical, exist.
Our High quality method make sure our customers acquire personalized reports with spots most suitable to their operations.
Require to make or augment your Quality Assurance staff with top talent? We help Many lifetime science organizations outsource their QA tasks and fill specialised roles through handy personnel augmentation and recruitment.
With much more check here than twenty years of encounter with FDA, Overall health Canada, EU and international regulatory companies throughout the world, Regulatory Compliance Associates® delivers leading pharmaceutical consultants. We’re one of several couple pharma consulting organizations that can help you navigate the problems connected with sector rules.