Product

Pharma and Medical Device Regulatory Affairs

July 1, 2010

Pharmaceutical and Medical Device Regulatory Affairs is an essential benchmarking tool to help teams ensure successful product launches. Explore structure models, internal processes and best practices, strategies for improving interactions with regulatory agencies, and detailed spending and staffing metrics. Consult clear, pointed recommendations for drug and device firms gleaned from executives at 50 life sciences companies.

Now more than ever, regulatory teams play a pivotal role in advancing commercial and clinical goals. They work under pressure to overcome a sizeable challenge in the current climate: Ever-changing policies and stringent submission protocols that can derail approval and market entry.

Regulatory affairs structure models

It is never too soon to start mapping a product’s regulatory pathway. Regulatory groups participate in product development in the initial stages – sometimes even before Phase 1 – and continue after launch. Early involvement is crucial in setting product direction and addressing problem areas at every step.

Learn how other companies increase access to key stakeholders and eliminate internal communication barriers. Innovative regulatory affairs structure models will show you how the right structure can help you solve problems faster.

Regulatory intelligence

Regulatory intelligence teams’ responsibilities often overlap with other regulatory groups, including due diligence. As such, some executives consider the function a luxury. But regulatory intelligence is crucial to tracking policy changes, sharing them company-wide, and providing decision support. These tasks are especially important as companies grow more global and communication more complex.

Discover novel strategies to disseminate regulatory intelligence, and find the one that works for you. Expand your understanding of regulatory intelligence so you can streamline activities and solidify strategy.

Regulatory agencies

Compared to just a few years ago, 50% of companies face longer timelines in preparing submissions and getting them approved. Success depends on coordinating with regulatory agencies and catering submissions to their specific requirements. In addition to establishing working relationships with agencies early on, teams should keep the agencies’ communication preferences fresh in mind.

To help your team make the most of interactions with regulators, our research identifies factors influencing communications, including timelines and frequency. As you perfect your tactics, use others’ past experiences to your advantage – and absorb recommendations specific to pharma and medical device firms.

Regulatory affairs groups serve a critical role for pharmaceutical, biotech and medical devices companies. Equip your team with the resources to generate the best possible product support, using our spending and staffing benchmarks to guide you through resource allocation. Track outsourced activities and funding to understand why teams use vendors – and how much they spend on them.

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