So you may be a start-up or virtual life sciences company, but you still have a requirement to have a Quality System to develop your pharmaceutical/life sciences products. That’s true if you are a company that is regulated by the FDA and major international regulatory agencies that conform to ICH guidelines.
Although you’re not likely to be inspected as an early stage company, regulators still expect that developers of human products must be stage appropriate managed in terms of compliance expectations for the products they are developing and commercializing. So you just can’t leave it for later because you’re not going to be inspected. The regulatory agencies expect that you comply with the law even though they’re not necessarily checking up on you.
Modern regulatory agencies require companies to have Management Controls and a Quality Plan in place even when their product development is at an early stage.
As a result you can’t just leave it to your vendors and work off their systems.
This is a much misunderstood concept that is often overlooked because it takes time and expense to develop and put in place. However, given that it is the law, those ignoring the issues and failing to address the need are really jeopardizing their future business and products.
Companies intending to partner with large pharmaceutical companies will find that they can negotiate better terms if they have their compliance house in order. Large Pharma likes positive results and will pay for the convenience of an in-license, but if there are regulatory issues as a result of a lack of quality oversight they may be less inclined to pay top dollar as some of that amount may be needed to address regulatory short falls.
A better business & compliance approach is to do it right first time and to initiate a flexible and expandable Quality System strategy.
At SCG we offer a fully expandable and serviceable Quality System that’s been tried and tested over a number of years at start-up, clinical and commercial scale.
Developed from first principles using process mapping, our system is sensitive to the requirements of commercial rigor without stifling development for earlier stage situations.
Talk to us about our early start QMS package and reap the benefits of being in compliance right from the development inception. This is a must do for virtual or blended outsourced business models.
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