We work closely with our purchasers to travel innovation and progress the development of solutions to provide to people. We do the job with pharma leaders to help their businesses optimize effectiveness when balancing excellent and regulatory specifications. Our advisors Use a prosperity of sector-dependent R&D useful know-how and strategic consulting knowledge using a deep comprehension of finance, tax, possibility administration, compliance, operations and human resources.
With permanent placement from your FDA Team, you can accomplish a few Key aims: minimize the price of talent identification and shipping and delivery, get the assured high quality of new hires, and mitigate the pitfalls of recruiting new staff.
“Kellerman Consulting acted like a coach for our new QC retain the services of, so we benefited from that in addition to the thriving planning with the SQF audit. We bought a 98% to the audit. That ought to communicate for itself.
Kellerman Consulting does an amazing occupation of constantly Assembly consumers’ expectations and having time to be familiar with the wants in their special buyer. Their assistance goes higher than and over and above expectations.
We’re grateful for his flexibility in his session programme maintaining the tiresome paperwork and documentation to minimum amount stage. Something I am most joyful about is my crew didn't complain about obtaining more paperwork.
Equipment and Utensils: Acceptable equipment and utensils that are resistant to corrosion and straightforward to wash
Premise and creating: The factory building needs to be designed, created, modified, and managed to accommodate the manufacturing actions, enabling with the manufacture of medications under get more info sanitary circumstances.
“We partnered with Kellerman Consulting incredibly early on inside the SQF certification method, and by counting on their abilities and methodical approach to gathering, compiling, and organizing the necessary documentation, we had been prosperous in gaining our certification.
How do we do it? By Doing work intently together with your crew and by pursuing our repeatable and trustworthy approach.
Our companies are backed by a complete Top quality Ensure. If for almost any reason, you will be dissatisfied with any service, We are going to give you an entire refund.
Our workforce of knowledgeable regulatory researchers can write the nonclinical, medical, and CMC sections in CTD and regular format in your new drug and biologic programs.
I hugely suggest read more working with Kellerman Consulting. Dealing with Brian Kellerman put me at relieve. He’s really instructive, affected individual, and took some time to stroll me by way of the process. An all around great guy! If ever I need the expert services this business gives I’ll appear no further.
But In addition, it comes with issues, pitfalls, and tasks. In the following paragraphs, We're going to take a look at a lot of the pros and cons of becoming a GMP specialist or contractor, and ways to evaluate your suitability and readiness for this vocation path. Major gurus in this article Selected with the Neighborhood from 24 contributions. Find out more
PharmOut are the biggest service provider of GMP consulting products and services from the region. Examples of what we will offer contain but are usually not restricted to: