Don’t forget the regulatory strategy!
Don’t forget the Regulatory Strategy! As an expert regulatory affairs and drug development consultant, I can always tell when a client has not prioritized the development of the regulatory strategy. They are always the ones running into challenges and road blocks. The road blocks often include concerns that seem to comeout of mid-field. They were usually not predicted, and slow down the program.
Why wouldn’t a firm develop a regulatory strategy? The purpose of the regulatory strategy is to carefully consider the various options open to the firm, for the drug, from the very outset. It allows the regulatory expert to consider the end, from the very beginning. The importance of this cannot be under-estimated.
This makes perfect sense, doesn’t it? Yet, I wish I had a $100 for the number of times clients have said, there is no need to waste time on the regulatory strategy. They just haven’t understood why it is so important. I understand why they don’t want to do it. The process is detailed, and time consuming, and can therefore be expensive, but it pays dividends.
The regulatory strategy takes into account the latest guidelines, as well as guidelines that have been around for a long time. It takes into account the needs of the patient group, as well as the potential for competitive products to make it to market before your drug, and impact the marketplace before you can.
Therefore, don’t ever forget the regulatory strategy.