- Becoming a member of our IGAP application/ Audit report library is totally free for suppliers/manufacture. Our experienced and qualified auditor will complete entire web-site audit of supplier covering significant number of molecules/solutions (Otherwise presently performed) without charge to supplier and in-depth audit report shall be ready.
We're going to review your documentation and check out your facility, establish gaps within your existing system and facility operations, and we will allow you to fill Those people gaps so as to pass your audit.
GMP consultants with QA practical experience know how Every single department within the Group interacts with the manufacturing processes and systems. QA industry experts have a complete picture in mind when coming up with an outstanding management process and they are very experienced in federal, nearby, and Skilled standards.
Kellerman Consulting’s GMP consultants provide a created quality & foodstuff basic safety manual that's tailored towards your solution, procedure and operation. We provide high quality consulting and food stuff protection training In keeping with current FDA regulatory requirements and custom-made to the GMP certification scheme that you will be wishing to get Licensed against.
Our group of knowledgeable regulatory experts can write the nonclinical, scientific, and CMC sections in CTD and common structure in your new drug and biologic applications.
“Kellerman Consulting was Expert, efficient, and carries on to show their aid and assistance even once the GMP audit”.
which were vital towards the profitable completion of this method. I would hugely endorse Kellerman Consulting for almost any of one's consulting desires as they had been very Experienced and ensured that every one merchandise were dealt with previous to our audit. “
Confident source chain with competent suppliers and sturdy procedures is eventually The idea for minimizing issues and making sure medicinal product safety.
I really recommend working with Kellerman Consulting. Working with Brian Kellerman put me at ease. He’s very enlightening, client, and took some time to wander me by the process. An throughout great man! If at any time I would like the companies this read more enterprise supplies I’ll seem no additional.
This and the precise description of the necessities and procedures allows the enough adaption with the equipment to the real need within your GMP process.
Which has a merged tenure get more info throughout our businesses of nearly two hundred years and our field-identified scientific and technological know-how, we aid to ensure the basic safety of over 190 million people and Health care practitioners world wide each and every year.
It contributes to improved sector pace and elevated transparency and accountability all through various businesses linked to formulation (throughout a number of dosage forms), API and biosimilar.
As your partners, Regulatory Compliance Associates can negotiate the opportunity minefield of regulatory compliance and regulatory homework with Perception, hindsight, plus the apparent advantage of our special skills and practical experience.
Prior to the introduction of medicinal solutions to the marketplace, the regulations of fine Observe (GxP) ought to be adopted throughout generation and advancement.