Within drug development, regulatory affairs is all about making the right decisions and taking the right actions at the right time. Let’s be frank, timing is not always an easy feat. We know that many drug development projects fail due to either running out of time or funding, not being adequately prepared before interacting with the authorities, or due to study design-related mistakes. Not because the idea itself is scientifically bad. It’s probably not.
Imagine this. You’ve been working on a drug project for years and you’re at the top of the game when it comes to the details of and science behind the drug itself. Now, without the proper regulatory strategy (i.e doing the right things at the right time), your project is at serious risk of not gaining regulatory approval, meaning that at the end of the day, patients will not receive the help they need in the form of your intended treatment. Or they will not receive it in time.
Remember, one mission of the regulatory authorities is to ‘’foster scientific excellence in the evaluation and supervision of medicines, for the benefit of public health’’. In other words: in the interest of the patients, regulatory authorities want you to interact with them and ask for advice. The question is which body you should approach when, and how.
Our services within regulatory affairs make sure you decrease the risk of failing within the development of your product or avoid unnecessary delays. We evaluate any opportunities for ‘’expedited pathways’’, a technical term for various regulatory fast-tracking possibilities intended to significantly reduce time to market.