Experience and Relationships with Regulatory Personnel Pay Dividends in Accelerating Regulatory Submission Timelines

Available resources and regulatory affairs experience are top factors in accelerating or lagging regulatory submission timelines for life science companies, says Cutting Edge Information

RESEARCH TRIANGLE PARK, N.C.--(BUSINESS WIRE)--A recent study of life sciences companies found that 69% of medical device and small drug companies experience long regulatory submission timelines. By comparison, 72% of large pharmaceutical companies experience short, or relatively stable, submission timelines.

“At small companies, communication with regulatory bodies tends to be limited to written correspondence, rather than the direct links that larger companies enjoy.”

The study, “Regulatory Affairs: Safeguarding Submission Success and Product Development Strategy” by Cutting Edge Information found that companies’ perceptions of regulatory timelines depend on size. Only 27 percent of large pharmaceutical companies reported experiencing long regulatory timelines; 31% of medical device and small drug companies reported steady or stable timelines.

Larger companies leverage greater resources and hire more regulatory experts to position themselves for expedited product review times, according to the study. Their larger headcounts, more experienced regulatory affairs personnel and established agency relationships contribute to more streamlined processes.

“The regulatory affairs team’s level of experience is a key difference between larger and smaller companies,” said Ryan McGuire, research team leader at Cutting Edge Information. “At small companies, communication with regulatory bodies tends to be limited to written correspondence, rather than the direct links that larger companies enjoy.”

Experience has becoming a necessity to ensure successful submissions and to manage growing workloads, according to McGuire. Few regulatory agencies are incentivized to communicate directly with life sciences employees about submission issues. And veteran regulatory affairs executives are more adept at preventing mistakes in the first place, which saves critical time and money.

“As pharmaceutical compliance demands increase and regulatory requirements grow more complex, regulatory affairs teams are playing an even bigger role in compounds’ and even companies’ success,” McGuire said.

“Regulatory Affairs: Safeguarding Submission Success and Product Development Strategy” (http://www.cuttingedgeinfo.com/research/regulatory/market-approval/) contains resource benchmarks, strategic recommendations and best practices for building a strong regulatory affairs team and improving regulatory submission timelines. It will guide key decision-makers to:

• Overcome hurdles in your regulatory process to move your products to market sooner.
• Position regulatory affairs at the center of strategic activity.
• Benchmark the most desired skills for regulatory employees and hire accordingly.

For more information about regulatory affairs benchmarking, contact Elio Evangelista at [e-mail] or [phone].