“The corporate’s capability to integrate production and dosing definitely accelerated the perform of the examine and was one of many main causes that Corcept Therapeutics picked Quotient Sciences to undertake the research.”
At Regulatory Compliance Associates, we provide the pharma consulting experience and pharma consultants important to guidebook you through the high-quality compliance process.
Throughout your free of charge GMP consultation, you’ll discover what the requirements are for getting certified, the amount of it charges without any concealed fees, how much time it's going to take, and how our process performs to assure you move your GMP certification audit on the primary check out.
Draw on our in depth material skills for a shortlist of candidates screened to fit your necessities.
In The existing surroundings of poor merchandise pipelines and broader shopper bases, the traditional product sales and marketing model of driving revenue with at any time-larger sized income forces is no more sustainable.
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Kellerman Consulting has supported many shoppers nationwide to productively move their regulatory inspections and their GMP and cGMP certification audits.
“Quotient Sciences’ authentic-time manufacturing capabilities were being a essential Think about figuring out the velocity at which this review may very well be concluded, supplying the uncommon combination or GMP producing and medical administration on the exact same internet site, even for intricate formulations and dosage forms. This authorized us to development much faster.”
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We work with our clientele to audit and acquire administration units that enable bigger transparency over the company, advise the development of latest strategies to some wide array of regulatory and tax compliance, and enable improve general performance.
How will obtaining GMP certification with all your direction elevate our manufacturer reputation and instill self-assurance within our individuals?
Nevertheless, with huge growth, the business is also experiencing hindrances and striving to manage up Along with the predictions. Handling the growing R&D costs and intense Levels of competition, handling dwindling solution pipelines, sustaining real-time visibility through the supply chain, website and many others are a few the troubles that should be resolved by supplying radical solutions. On top of that, the pharmaceuticals and biotech sector is Amongst the most intensely regulated click here industries on the globe and demand sturdy programs and procedures in place to fulfill international compliance. In this sort of scenarios, it results in being more and more important for these kinds of providers to have a program that assist them simplify these regulatory complexities.
We're going to assessment your documentation and take a look at your facility, discover gaps within your existing method and facility functions, and we will help you fill Individuals gaps in an effort to move your audit.