Ana’s built-in vision of Pharmaceutical Quality Methods serves her effectively in collaborating with interior and external buyers to equilibrium compliance with simple, healthy for use solutions.
Our workforce of professionals has properly completed a lot of hole analyses in over the past 20 years and provides this consulting company for all GMP techniques.
As your companion, we are able to negotiate the opportunity assessment minefield of regulatory compliance companies with insight, hindsight, plus the obvious advantage of our breadth and depth of data and regulatory compliance consulting. We offer the next pharma consulting regulatory affairs expert services for pharmaceutical companies.
Continuity and also further availability throughout potential intense organization durations is ensured.
Our team of skilled regulatory experts can write the nonclinical, medical, and CMC sections in CTD and traditional format in your new drug and biologic apps.
The effects of files and on-website checks are documented and the observations and determined deviations about GMP specifications are discussed.
We develop remarkable leaders who workforce to provide on our guarantees to all of our stakeholders. In so performing, we Enjoy a significant function in creating a far better Doing work planet for our people, for our customers and for our communities.
scarce diseasecell & gene therapyoncology & hematologydermatologymedtechneurosciencepediatricsanalgesiawomen’s health Foremost just how
We don’t spread ourselves slim across different industries. Alternatively, we concentrate on furnishing a deeper, richer bench of lifetime science talent at the speed you will need. Our significant staff of internal means and extended global network give entry to specialists anywhere you'll need them.
I couldn’t have requested for a much better firm to help you us work on our certification. They were beneficial, academic, and received our program productively transformed with crystal clear professionalism.
Tim and Brian rallied all over me and manufactured absolutely sure more info I used to be all set to fulfill the problem head on. From composing and examining paperwork, to educating a complete novice, to performing a mock audit in advance, the Kellerman workforce created guaranteed we have been All set not merely to pass, but to score a 91 on our very first audit. I could not suggest them far more really”!
All of our full-time GMP consultants are very well-versed in Kellerman Consulting’s repeatable and reliable procedure. Our crew’s collaborative culture provides the good thing about our collective expertise with hundreds of prosperous results.
Clarkston’s pharmaceutical consultants aid our customers build and activate methods to deal with their certain worries and rising trends to generate enterprise.
“They are really so Skilled and it had been just a real pleasure Doing work by way of almost everything. I might Totally advise Kellerman Consulting. I already have. When persons inquire me about check here the SQF consulting process, I would not hesitate to convey," unquestionably get in touch with Kellerman Consulting'' ” .