“The company’s capability to integrate manufacturing and dosing really accelerated the perform of the review and was among the list of principal causes that Corcept Therapeutics chosen Quotient Sciences to undertake the study.”
Faucet into assorted competencies and skillsets for your predetermined or open-ended length of time based on your evolving requirements.
What precise subjects and modules does your GMP training cover to equip our workforce with the necessary abilities and understanding for compliance?
One of many environment's leading gatherings on the way forward for science & engineering. Abstracts due March 31st, 2024
Ellab gives you an at any time-rising supply of data on different validation processes, programs and items.
Tim and Brian rallied all over me and produced certain I was prepared to meet up with the challenge head on. From creating and reviewing paperwork, to educating a complete newbie, to executing a mock audit in advance, the Kellerman group manufactured confident we were being All set not only to move, but to attain a ninety one on our to start with audit. I couldn't advise them extra very”!
- 360 degree audit solution To guage the abilities and top quality devices of suppliers and out-sourcing companions
On-phone real-time support for the duration of your GMP audit and ongoing guidance after the audit till you might be certified, regardless of the.
You take pleasure in the aid of GMP consultants who review each challenge for a group. The co-founders of Kellerman Consulting are associated with Just about every project at every single stage to ensure that click here we have been delivering on our commitment to our clientele.
We try to assist boost outcomes and make a much healthier, a lot more sustainable globe for people just about everywhere.
Our workforce of knowledgeable regulatory experts can create the nonclinical, clinical, and CMC sections in CTD and common format to your new drug and biologic programs.
Working collaboratively, our regulatory specialists coordinate all components of your demo’s document assortment and submissions, which include:
If you have already got a facility design and style, we can offer an independent GMP critique to here make sure that many of the significant aspects are covered.
Kellerman Consulting arrived for the rescue for me following dealing with Yet another competitor who left me in the dead of night. I was so relieved to find a dependable, knowledgeable consulting agency who could aid a fresh operator out in building an entire blown HACCP strategy - and educate me alongside the way!