Small biotech and pharma companies struggling with regulatory submission timeline

Some 69% of small biotech and drug companies are experiencing longer regulatory submission timelines, in contrast with Top 50 and Top 20 Pharma companies where only 27% saw longer timelines, according to new findings by Cutting Edge Information. 45% of these larger companies are seeing shorter submission timelines, compared with just 8% of small companies.

The US Food and Drug Administration has recently implemented accelerated timelines and shorter evaluation windows, but it seems that smaller companies have been unable to take advantage of this. The study, titled Regulatory Affairs: Safeguarding Submission Success and Product Development Strategy, determined that fewer staff with less experience are a significant factor in getting through submission timelines quickly.