Having a mixed tenure across our firms of almost 200 several years and our sector-acknowledged scientific and technological know-how, we aid to ensure the protection of above one hundred ninety million clients and Health care practitioners around the globe every year.
You take pleasure in the assistance of GMP consultants who evaluation each challenge being a staff. The co-founders of Kellerman Consulting are involved with Every venture at each individual phase to make sure that we have been offering on our motivation to our clientele.
Our mission will be to speed up innovation for any much healthier globe. Together, we can fix client worries and enhance patient life.
An in-focus explore The nice Producing Practice (GMP) audit planet and how the idea of distant or virtual audits, a reasonably new thought is remaining adopted.
Our crew of professional regulatory experts can generate the nonclinical, medical, and CMC sections in CTD and regular structure for your personal new drug and biologic apps.
In addition, Every single Regulatory Compliance Associates pharma consulting Professional understands compliance enforcement. We’ll get ready a comprehensive pharma consulting technique to support in the remediation initiatives, push continuous advancement, and sustain regulatory compliance Along with the polices.
“Larsen Packaging check here Products and solutions is appreciative to Kellerman Consulting and our contact Tim Grady for assisting us in getting our GMP certification. Tim walked this journey with us from starting to conclusion and was always available to solution any inquiries and support us in building techniques, kinds, etc.
Operating collaboratively, our regulatory specialists coordinate all facets of your trial’s document collection and submissions, together with:
We will for that reason offer you this consulting support in each mode common out there. The design assessment can frequently be carried out with no corresponding on-web page presence, only determined by the complex documentation about the general and comprehensive planning of an set up.
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- We make sure your plant web-site fulfills your small business targets even though becoming fully compliant with the latest Very good GMP consultancy Producing Practice laws and requirements.
Now we have concluded a lot more than seven-hundred+ Seller/Provider Qualification audits. Regionally dependent consultants in wider geography so helpful top quality of labor without language barrier and journey constraints.
cGMP is often a step-up from GMP standards and is necessary for dietary dietary supplement makers. cGMP usually means Current Great Producing Apply. cGMP rules need more product or service screening plus more complete good quality administration devices in place.
This involves as an example, qualification, validation and deviation or transform management. The Hole Investigation is definitely an active comparison with the founded latest state While using the requirements specified by local or international GMP rules.