Say goodbye to uncertainties and have faith in us to tutorial you seamlessly from the ISO certification experience.
This realistic knowledge, coupled with our extensive idea of area and world-wide rules, positions us as an unmatched asset to any Group trying to get GMP compliance.
We perform along with you to create essentially the most appropriate formulation determined by the physicochemical and biopharmaceutics properties of your respective molecule.
Our expert existence science recruiters draw on comprehensive field know-how to completely recognize your hiring requirements and perform a rigorous identification and screening process to offer a shortlist of highly competent FTE candidates, specifically in specialised, competitive areas, like cGMP.
Transfer your Group ahead while keeping a steady and finish state of regulatory compliance. From regulatory observation responses to inspection readiness, our huge team of compliance specialists can tackle just about any regulatory obstacle.
Our mission is to speed up innovation for any healthier globe. Collectively, we could solve purchaser worries and increase patient lives.
We assessment the compliance of one's precise pursuits to GMP specifications and corporation data prior to your certification overall body audit.
Obtaining an auditor uncover non-compliances on your site could be a very high-priced way to find out that you don’t possess the depth of information or encounter in-dwelling to handle GMP compliance.
No matter if you’re within the merchandise organizing, improvement or pharmaceutical lifecycle management stage or need a remediation approach for just a compliance crisis, Regulatory Compliance Associates will information you through each pharmaceutical consulting move with the regulatory system.
We certainly will help you along with your ICH Q9 or ISO14971 danger assessments, or if you want training on this common. PharmOut gives An array of companies to enhance our GMP consulting products and services.
Our pleasure lies not just while in the choice of services we offer but will also within the individuals who produce these services. Quite a few our GMP consultants are seasoned professionals who definitely have served as GMP inspectors and also have a prosperous background of click here navigating the challenging environment of pharmaceutical regulations.
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Kellerman Consulting held my hand each action of how (and rely on me I necessary it)! Kellerman Consulting obtained me by all of my approvals by having an simple to comply with HACCP strategy that appeased a USDA regional supervisor.
Definitely a terrific satisfaction to work with Koh. His company offer entire customised ISO units for your company. Not "copy pasted" templates. What definitely stunned me was I asked for for speedy certification because of tender needs, he managed to acquire every little thing done within just 1 month.