We got through our audit and we are very very pleased to own acquired a ninety nine.37% score. I have already been Functioning For a lot of, many years and it is rather refreshing to work with another person which can be so Expert and do whatever they say they are going to do and nevertheless handle those with kindness.
You take pleasure in the assistance of GMP consultants who overview just about every task for a workforce. The co-founders of Kellerman Consulting are associated with Each individual project at each individual stage to be sure that we're providing on our determination to our shoppers.
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As a passionate student of marketplace, Ana is remarkably driven and dedicated to bringing benefit to both consumers as well as their source chain companions alike.
Our crew of experienced regulatory researchers can create the nonclinical, scientific, and CMC sections in CTD and common format in your new drug and biologic applications.
“Kellerman Consulting was Qualified, productive, and carries on to show their support and assistance even following the GMP audit”.
We understand your product or service and program the facility in accordance with Intercontinental regulatory specifications. The GMP certification session includes documentation and employees education Along with facility style and design.
Confident source chain with competent suppliers and robust procedures is in the end the basis for reducing complaints more info and guaranteeing medicinal product or service basic safety.
Presently all through progress and formulation, the first compliance measures for Good Producing Follow (GMP) should be carried out. These mainly include all GMP related subjects which can be to generally be applied on the hazard-based mostly strategy according to the respective enhancement stage.
Guarantee the caliber of your products and solutions by starting a QMS. Valicare's industry experts will support you with QM consulting, document preparation & implementation.
We can easily satisfy clinical contracted and direct use resource placement needs in many different roles and capabilities such as,
The appropriate supervisory authority checks the lawfully compliant design within your QMS and may only grant your business a permission for the action in concern if all procedures are explained in compliance Together with the regulations.
PJC Pharma Consulting delivers a purchaser-targeted pharmaceutical consultancy and parenteral consultancy company, supplying specialized steering for solution development, education, vital process assessments, audits and project administration. With thirty a long time’ experience from the pharmacy/pharmaceutical industry, we deal with more info a spectrum of tasks from generic portfolio development and registration to machine advancement and registration, and new chemical entity advancement to scientific section.
With a lot more than 20 years of practical experience with FDA, Health and fitness copyright, EU and worldwide regulatory businesses globally, Regulatory Compliance Associates® features primary pharmaceutical consultants. We’re among the list of number of pharma consulting businesses which will help you navigate the difficulties associated with business restrictions.