Do you want assistance or assistance on one or more of those matters? Our knowledgeable professionals will accelerate the entry within your products in the pharmaceutical/biotech industry.
Shift your Corporation ahead though maintaining a continuous and entire point out of regulatory compliance. From regulatory observation responses to inspection readiness, our huge staff members of compliance professionals can deal with just about any regulatory problem.
A lot of our organic scientists and engineers are familiar with staying in management positions and, if demanded, also inside your organization.
The polices approach surrounding pharmaceutical businesses is often challenging for even essentially the most expert field veteran to be aware of. Just one misstep could imply sizeable and lasting penalties for your online business.
Therefore, these pursuits needs to be prepared intimately Together with the finish in your mind, such as the regulatory, task funding, the future growth for the types of items Based on supposed commercial marketplaces Along with the power’s nation of location.
“Kellerman Consulting was Qualified, successful, and proceeds to show their assistance and assistance even once the GMP audit”.
“Larsen Packaging Goods is appreciative to Kellerman Consulting and our Speak to Tim Grady pharma consultants for aiding us in obtaining our GMP certification. Tim walked this journey with us from beginning to close and was normally available to solution any issues and assist us in developing techniques, kinds, and many others.
World-wide offer chain disruption and API scarcity will drive the field to diversify sourcing destinations and establish new provider networks – all when delivering real-time, whole-product visibility and traceability.
We have now an A score with BRCGS and I attribute that to Brian Kellerman and Kellerman Consulting for almost everything they've got carried out to aid our organization to obtain the certification. Their Original assessment of our organization, the files, and information provided to make our
I couldn’t have questioned for an improved organization to help us work on our certification. They had been valuable, instructional, and acquired our plan successfully converted with obvious click here professionalism.
EY is a worldwide chief in assurance, consulting, system and transactions, and tax services. The insights and high-quality companies we supply assist build belief and confidence while in the capital markets and in economies the planet about.
It causes improved market place speed and increased transparency and accountability in the course of numerous companies linked to formulation (throughout numerous dosage forms), API and biosimilar.
On-phone real-time assist through your GMP audit and ongoing help after the audit until eventually you will be Qualified, no matter what.
- When report essential on urgent foundation to assistance the provision, regulatory submissions etcetera., When production web page can’t accommodate the audit due to busy program, When vacation restriction; Sponsor will get benefits by obtaining our IGAP studies from our report database, Additionally our purchasers only commit a small portion of the costs normally associated with conducting a supplier audit.