Kellerman Consulting arrived into the rescue for me just after dealing with Yet another competitor who still left me in the dark. I was so relieved to find a dependable, professional consulting firm who could aid a brand new operator out in creating a full blown HACCP approach - and instruct me along the way in which!
We’ll do the job alongside you to definitely implement your GMP certification system, making sure you understand how to operate it and that you just pass your next audit.
The majority of our pure experts and engineers are accustomed to staying in management positions and, if needed, also in just your business.
It’s a pharma consultancy Established by regulatory compliance executives through the pharmaceutical sector. Each and every pharmaceutical market specialist about the Regulatory Compliance Associates staff understands the exceptional internal workings in the regulatory method.
As a result, these functions needs to be planned intimately Using the conclusion in your mind, including the regulatory, task funding, the future growth for the categories of items In keeping with meant business marketplaces Together with the power’s region of place.
“Kellerman Consulting was Experienced, economical, and continues to point out their assist and steerage even following the GMP audit”.
Regulatory affairs is Regulatory Compliance Associates spine. We exceed other pharma consulting providers with sector professionals expert in complexities of your pharmaceutical and biopharmaceutical industries.
Confident source chain with experienced suppliers and robust processes is eventually The idea for reducing problems and making sure medicinal solution basic safety.
In addition to parenterals PJC Pharma Consulting can present a variety of support for other dosage types, from candidate selection as a result of to NDA/MAA submissions, equally For brand spanking new chemical entities and products line extensions (PLEs) of numerous oral dosage formulations: Tableting
During your absolutely free GMP consultation, you’ll find out what the necessities are for getting Accredited, how much it prices without concealed charges, just how long it requires, and how our procedure works to assure you move your GMP certification audit on the very first consider.
We will fulfill scientific contracted and immediate website retain the services of useful resource placement needs in a variety of roles and capabilities such as,
Producing IQVIA’s positions on essential developments in the pharma and daily life sciences website industries, which has a target EMEA.
Fantastic Production Techniques (GMPs) can also be called prerequisite systems, or foodstuff basic safety and top quality fundamentals. These are generally the website and corporation certain rules and daily functions put into spot to hold goods Protected. GMPs may very well be penned down or communicated verbally and are commonly enforced by means of Excellent Assurance or management personnel.
Regulatory Compliance Associates Quality consulting contains assessments, system, implementations, employees augmentations, and identification of top quality metrics to be sure continual advancement. Our pharma consultants understand the strategic pondering necessary to align your enterprise requirements and plans.