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Bringing a new drug to market is a highly complex process – with much of the complexity having nothing to do with the science. There are complicated regulations, strenuous process requirements – and the paperwork! Even for established pharmaceutical companies, and even after successful drug commercialization, ongoing verification requirements and control changes can interrupt normal business activities, resulting in warning letters, fines, or worse. That’s why many organizations choose to work with a dedicated process validation partner.
With an effective process validation regimen – with proper documentation and protocol testing to address product identity, strength, quality, purity, and potency – you can bring products to market faster while upholding the rigorous compliance standards of the FDA.
Here’s a quick look at how process validation works:
When considering all the requirements to meet regulatory standards, it’s understandable to feel overwhelmed. Keeping the end goal in mind can help, and so can working with an experienced expert. Outsourcing process validation to practiced professionals can help mitigate risk, ensure regulatory compliance for lab, and allow your scientists stay focused on their areas of expertise.
If you’d like to learn more, one of our dedicated experts would be happy to talk with you about your goals and challenges. Just submit the form below to get started.
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