At Regulatory Compliance Associates, we offer the pharma consulting encounter and pharma consultants essential to information you in the high-quality compliance method.
“We partnered with Kellerman Consulting very early on during the SQF certification process, and by relying on their knowledge and methodical approach to collecting, compiling, and organizing the essential documentation, we were being productive in gaining our certification.
Whether you are ranging from scratch, or you’d like us to incorporate your current programs, we’ll produce the program you need to get Accredited.
Kellerman Consulting’s GMP consultants provide a published excellent & foods protection handbook that's tailor-made to the product, process and Procedure. We offer high-quality consulting and food safety coaching As outlined by recent FDA regulatory specifications and customized to your GMP certification plan that you are wishing for getting Qualified from.
GMP consultants don't just aid keep compliance, but Additionally they establish opportunity regions of risk just before they turn out to be considerable issues.
How can we get it done? By working intently using your crew and by subsequent our repeatable and trustworthy system.
From R&D to provide chain and functions to every side of commercialization, pharma and biotech businesses really have to execute flawlessly across all dimensions should they hope to get.
We even have quite a few internal compliance techniques to make certain that information is shielded from exterior threats, like unbiased penetration testing.
With lean production expert, corporations and industries can experience our sustainable approach to scale their organization.
EY refers to the world-wide Firm, and should consult with a number of, with the member firms of Ernst & Younger World-wide Limited, Each individual of that is a independent authorized entity. Ernst & Younger World pharma consultancy wide Restricted, a United kingdom organization confined by assurance, isn't going to present companies to customers.
Tim and Brian rallied all over me and manufactured guaranteed I had been prepared to fulfill the obstacle head on. From crafting and examining documents, to educating a whole newbie, to doing a mock audit in advance, the Kellerman group designed sure we more info ended up All set not only to move, but to score a 91 on our to start with audit. I could not recommend them additional remarkably”!
Our Top quality procedure make sure our shoppers get customized reviews with places most appropriate to their functions.
The field of cell and gene therapy is evolving rapidly and experiencing ongoing technological, regulatory, and commercialization hurdles.
Clarkston supports late-phase scientific companies on their own route to commercialization. Leveraging deep sector expertise and regarded useful and enterprise approach Management that can help firms transition from growth to commercialization, guaranteeing sustainable, extensive-time period growth.