We offers turnkey high quality options and concentrates on offering Excellent Price effectiveness, while retaining maximum quality requirements for our Purchasers.
Whether you may need staff compensation for parental depart or for other limited-phrase vacancies - we provide you with the proper interim manager For each need profile.
Law corporations trying to get pharmaceutical consulting organization expertise while in the remediation of warning letters, consent decrees, 483’s or import bans
I'd personally remarkably advocate Kellerman Consulting to any person looking at this sort of certification for their Group”.
Our staff of knowledgeable regulatory experts can generate the nonclinical, scientific, and CMC sections in CTD and classic structure for your new drug and biologic applications.
Ongoing support: Our commitment towards your Corporation doesn’t finish with the supply of a session services. We believe in forging Long lasting partnerships, and as such, we provide ongoing aid and training to be certain your lengthy-time period GMP compliance.
We build exceptional leaders who team to provide on our promises to all of our stakeholders. In so executing, we Enjoy a essential part in creating a greater Doing work world for our people, for our customers and for our communities.
Regulatory Compliance Associates pharma regulatory consultants will produce a comprehensive proof e book of documented proof demonstrating the corrective motion taken to remediate non-compliant challenges.
By now for the duration of advancement and formulation, the initial compliance measures permanently Production Observe (GMP) has to be carried out. These essentially consist of all GMP applicable subject areas that are for being utilized with a chance-primarily based method according to the respective advancement phase.
For the duration of your cost-free GMP session, you’ll study what the requirements are for acquiring Accredited, the amount it prices with no hidden fees, how long it's going to take, And just how our system works get more info to assure you move your GMP certification audit on the primary consider.
A crew of long term GMP consultants, specialized in many fields of competence, supports you within your duties and problems with knowledge and foresight.
As your companion, we are able to negotiate the likely assessment minefield of regulatory compliance services with Perception, hindsight, and also the clear benefit of our breadth and depth of data and regulatory compliance consulting. We offer the next pharma consulting regulatory affairs providers for pharmaceutical corporations.
As these paperwork tend to be the key to an effective and mistake no cost operation of the GMP device, they ought to in shape to one another and to the size of the customer facet.
This features such as, qualification, validation and deviation or change administration. The Gap Evaluation is an Energetic comparison on the recognized current state Along with here the prerequisites specified by local or Intercontinental GMP laws.