Having a mixed tenure throughout our organizations of nearly two hundred years and our business-identified scientific and technological expertise, we help to ensure the security of in excess of 190 million sufferers and Health care practitioners around the world every year.
Our workforce of gurus has properly completed quite a few gap analyses in during the last twenty years and features this consulting services for all GMP devices.
- When report required on urgent foundation to guidance the provision, regulatory submissions etcetera., When manufacturing website can’t accommodate the audit resulting from busy schedule, When travel restriction; Sponsor will get Rewards by acquiring our IGAP experiences from our report database, Also our consumers only invest a small fraction of The prices usually affiliated with conducting a supplier audit.
Zero Accident: The chance of slipping, dangers connected to energy or handling of equipment, street hazards, plus more. Every day, the notice of each and every and each worker is critical to avoid mishaps within the place of work and to stop occupational health problems.
“We knew if we desired to get the place we desired to select our organization and securing a number of those big prospects, that we necessary to have SQF certification. When I first started out conversing here with Kellerman Consulting, I knew they ended up specialists.
As your associates, Regulatory Compliance Associates can negotiate the possible minefield of regulatory compliance and regulatory research with Perception, hindsight, as well as the very clear advantage of our exceptional know-how and knowledge.
Commissioning, Qualification & Validation We perform with our customers to develop scalable useful resource plans to guidance validation initiatives all through the job lifecycle. Whether it's drafting protocols to execution and compilation of information packs, our sources have you covered.
Legislation firms looking for pharmaceutical consulting business expertise during the remediation of warning letters, consent decrees, 483’s or import bans
In combination with parenterals PJC Pharma Consulting can offer an array of help for other dosage varieties, from candidate choice by way of to NDA/MAA submissions, the two For brand new chemical entities and product or service line extensions (PLEs) of a variety of oral dosage formulations: Tableting
I couldn’t have requested for a much better company to aid us work on our certification. They were being practical, academic, and received our software successfully converted with obvious professionalism.
R & D Provides mental home and regulatory guidance to make a sustainable, compliant model to create price.
We’ll assess your distinctive course of action and desires. Our workforce will write your GMP application tailored on your Procedure. We’ll coach you and your group on how to abide by most of the food items safety & quality strategies.
Do you need guidance or guidance on supplier qualification? Get hold of us and convey to us about your specifications. Jointly we discover the here best possible Remedy.
We make personalized assignments in compliance with FDA / USDA regulatory demands and GMP certification demands For each business we serve.