The rapid pace that regulatory guidelines are updated around the world can be dizzying for even some large and established regulatory affairs groups to keep up with. A well-managed regulatory intelligence group brings many advantages to companies, whether operating on a small scale domestically or on a large scale internationally. Regulatory intelligence can provide vital support to companies both pre- and post-launch.
Before products launch, companies trying to coordinate clinical trials in different locations, especially across the world, should be able to look toward a regulatory intelligence group. This group will make sure that it is aware of changes in regulatory guidelines that might alter trial timelines or protocols. This group must have the research capability to gather new information, whether through trusted local vendors and experts in different locations or similar in-house capabilities.
After a product launches, regulatory intelligence groups can support marketing and brand team groups by anticipating and then implementing internally new regulations regarding pricing, reimbursement or marketing activities. As many of these post-launch activities require careful documentation and justification for all decisions, any advance notice or advice that a regulatory intelligence team can offer regarding new guidelines is a substantial boost for these groups.
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