White Paper

Developing a drug is difficult. Going to market shouldn’t be

One of the major hurdles when launching a new drug is the approval of chemistry, manufacturing and controls (CMC) data, which is necessary in order to begin clinical trials and obtain final drug marketing authorization.

CMC modules are uniquely challenging because they:

  • Depend on regulatory requirements that can be difficult to find and verify
  • Consist of thousands of files and confidential company data
  • Rely on highly specific technical expertise to interpret

As a result, many new drug approvals take much longer than planned because of deficiencies in their CMC data, leading to extended timelines, unplanned costs and testing, and loss of forecasted revenue.

  • $432M – The expected spend on CMC activities for a company with a $2.9B R&D budget*1
  • 11.3% – The percentage of first-cycle review rejections due to CMC related issues2
  • $15M – The average cost of a delay in launch per drug, per day3

Download our latest white paper to learn how this plays out in one of the world’s fastest-growing markets: the Middle East. While the region is burgeoning with opportunity for the pharma sector, complexities in the regulatory system must be overcome to achieve market access. Fill out the form for access to the full white paper.

* $2.9B was the average R&D budget for the 17 large and mid-sized companies in CMR
1. 2018 CMR Factbook from Clarivate Analytics: Drawn from the 2018 R&D Investment Metrics Programme
2. https://jamanetwork.com/journals/jama/fullarticle/1817795
3. http://www.pharmexec.com/no-time-delay