Looking for FDA Approval?

Understanding the ins and outs of the regulatory landscape can be tricky. That’s why I’ve dedicated my career to helping companies navigate the process, with the goal of receiving FDA approval.

Helping startups navigate the FDA regulatory process is a passion of mine – and one that I’ve found extremely rewarding over my 35+ years in the industry. While no one has a magic eight ball to predict FDA approvals, I’ve worked hard to understand the regulatory perspective – and most importantly, how to help companies get through the process successfully. And it doesn’t just stop there. It’s equally as important to support a client not just through the initial approval, but through the entire lifecycle of the drug.

So how do you lead a company to FDA approval? I always start with three things…

Establish Trust

Leading a startup to FDA approval is like teaching someone to walk before they can stand up. Oftentimes, the company may feel a bit overwhelmed and panicked by the whole process. That’s why my first priority is to instill trust. The great thing about bringing in a consultant is the ability to be impartial. I may not have seen this company’s specific drug in the past, but I’ve seen a lot – and I know how to manage regulations around new drugs. I like to pinpoint a company’s specific goals and challenges with them, so that we can calmly figure out solutions together. I know how to talk to the FDA, but the company knows their drug best. Once the trust between company and consultant is established, we’re one step closer to our goal.

Manage Expectations

One thing to know about the regulatory process: nothing happens fast. That’s why it’s really important to level set clients’ expectations from the get-go. FDA approval is possible for any company – regardless of size – but that doesn’t mean the process will be quick. Truth be told, there is no “one-size-fits-all” approach and, although strategic guidance is undoubtedly helpful during the process, FDA approval is never a guarantee. When dealing with a startup, sometimes their innovations are so new and novel that the FDA doesn’t know how to regulate it. I’ve seen this more and more lately.

However, in the end, it makes the process that much more satisfying. We have a solid methodology to help manage risk – so no project is too big or too small. We can always find a solution.

Fail Fast.

Developing new drugs involves managing risk of failure. The risks are high, and the odds are not in our favor. When dealing with valuable internal resources (e.g., time, money, etc.), failing fast is very important. For example, many startups incorrectly believe that nonclinical and clinical development is all that matters – but this isn’t true. The FDA places great emphasis on the Chemistry, Manufacturing and Control (CMC) module which includes the controls for the Active Pharmaceutical Ingredient (API) and Finished Dosage Form. A tough part of my job is delivering the bad news – but the sooner we know of the FDA’s regulatory requirements, the quicker the company can address the feedback and move forward with their journey.