Small Biotech and Pharma Companies Struggling with Regulatory Submission Timeline

Smaller Staff, Limited Budgets and Less Experience Hamper Smaller Companies, Cutting Edge Information Finds

RESEARCH TRIANGLE PARK, N.C.--(BUSINESS WIRE)--A new study finds that 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. 45% of these larger companies are seeing shorter submission timelines, compared with just 8% of small companies.

“Regulatory agencies are not likely to negotiate with regulatory affairs employees over submission issues: either the submission is complete or it is not”

The FDA 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, “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.

“Regulatory agencies are not likely to negotiate with regulatory affairs employees over submission issues: either the submission is complete or it is not,” according to Ryan McGuire, research team leader at Cutting Edge Information. “The greater experience possessed by larger companies allows them to avoid costly errors and delays in the submission process.”

Top 20 and Top 50 drug companies also report a greater level of communication with the regulators at the FDA. Larger companies often have extensive relationships with the FDA while smaller companies are limited to written correspondence that constrain their ability to build a dialogue and maintain a useful rapport with regulators. This relationship-building is attributed to the experience of the professionals on larger companies’ regulatory affairs teams.

“Regulatory Affairs: Safeguarding Submission Success and Product Development Strategy” (http://www.cuttingedgeinfo.com/research/regulatory/market-approval/) provides in-depth spending, staffing and timeline benchmarks, as well as case studies, to support and strengthen regulatory affairs teams. The report supports key goals identified by benchmark partners:

• Boost team productivity by attracting and retaining top talent.
• Stay competitive with year-over-year budget benchmarks and projections.
• Manage the impact of globalization by implementing processes and best practices to quickly adapt to changing regulations.

For more information about regulatory affairs, pharmaceutical compliance and effective submission processes and strategies, contact Elio Evangelista at 919-403-6583.