Top 8 Obstacles In Pharma & Biologics Products Registration & Submission Management

By Patricia Santos-Serrao

The process for developing a new drug and bringing it to market typically takes 10 to 15 years. That average takes into account one country, such as the United States. Add to the registration and approval process other countries and you can factor in a few more years to that timeline.

The average cost of developing a new medicine is estimated at $2.6 billion, a figure that also covers the cost of failures. Not to be pessimistic, but it’s important to think about failures given that the U.S. Food and Drug Administration (FDA) approves only 12 percent of drugs that undergo clinical trials. Taking all of this into consideration, life science organizations can’t afford any delays in product registrations and overall time to market. As with many industries, time is money.

Based on my 20-plus years of experience in the pharmaceutical industry, I have seen a variety of obstacles that result in delays to registrations, many of which can be avoided using sound business processes and leveraging technology to automate processes. I have identified some of the most common problems below and shared some insights on how best to address them.