Pharma and Medical Device Regulatory Affairs (PH132)
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- Published 2010
- 124 Pages
- 300+ Metrics
- Charts and Diagrams
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Guarantee smooth approvals with a top-flight medical regulatory affairs team
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.
Get it Right the First Time
It is never too soon to start mapping a product's medical regulatory pathway. Medical 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.
Empower 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.
Engage 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 regulatory affairs and medical device firms.
Allocate Resources Appropriately
Medical 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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Companies Included in Medical Device and Pharma Regulatory Affairs Research
- Abbott Labs
- Alcon Labs
- Allergan
- AngioDynamics
- Archimedes Pharma
- Ariston Pharma
- AstraZeneca
- Aritech
- Bausch & Lomb
- Becton Dickinson
- Beckman Coulter
- Biogen Idec
- Bristol-Myers Squibb
- Cardio3 BioSciences
- Centocor
- Corventis
- Davol
- DuPont
- Fleming Pharmaceuticals
- Fresenius Medical Care
- Genzyme
- GlobeImmune
- GlaxoSmithKline
- Haupt Pharma
- Hoffmann-La Roche
- Hospira
- Jazz Pharmaceuticals
- Johnson & Johnson
- MedImmune
- Medrad
- Medtronic
- Merck & Co.
- Merck KGaA
- MiddleBrook Pharmaceuticals
- Novo Nordisk
- Oasmia Pharmaceutical
- Ortho-Clinical Diagnostics
- Otsuka Pharmaceutical
- Peregrine Pharmaceuticals
- Pfizer
- PLIVA
- Roxane Laboratories
- Sovereign Pharmaceuticals
- Stryker
- Suneva Medical
- Tokai Pharmaceutical
- Welch Allyn
- ZARS Pharma
- ... and more
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Medical Device and Pharma Regulatory Affairs Metrics
Chapter 1: Integrating Regulatory Affairs in Pharmaceuticals with Product Development
- Regulatory affairs structure (dedicated department, arranged by therapeutic area or other)
- Breakdown of structure by company type
- Reporting relationships by company type
- Position leading regulatory affairs
- Organizational charts
- Organizational charts showing regulatory intelligence structures
Chapter 2: Communicating with Regulatory Agencies
- Reasons for lengthening timelines over the past three years
- Factors having the greatest impact on regulatory affairs over the past three years
- Frequency of contact with regulatory agencies by company type
Chapter 3: Regulatory Affairs in Pharmaceuticals Staffing and Budgets
Staffing
- Percentage of companies that outsource some portion of regulatory affairs work
- Change in regulatory affairs staffing: 2007 to 2010
- Average increase in FTEs by company type: 2007 to 2010
- Average number of FTEs dedicated to regulatory affairs by company type
- Average FTEs per regulatory affairs position by company type
- Differences in drug and device regulatory systems
- Number of FTEs dedicated to regulatory affairs - broken out by company type
- Percentage of companies' regulatory affairs departments that maintain a dedicated budget
Budgets
- Breakdown of departments funding regulatory affairs at companies with non-dedicated budgets
- Average regulatory affairs budget by company type
- Responding companies' regulatory affairs department responsibilities by activity
- Companies' regulatory affairs budgets — broken out by company type and by activity
- Affairs department responsibilities by activity
- Average budget per activity across all companies
- Percentage of average budget per activity across all companies
- Average budget per activity for companies that conduct the activity
- Average percentage of budget per activity for companies that conduct the activity
- Funding level changes since 2007 — also broken down by company type
- Comparison of regulatory budgets by company type: 2007 to 2010
- Average increase in regulatory affairs budgets by company type: 2007 to 2010
- Average percentage increase in regulatory affairs budgets by company type: 2007 to 2010
Outsourcing
- Regulatory outsourcing percentage by company type
- Percentage change in regulatory affairs outsourcing by company type
- Average regulatory affairs outsourcing budget by company type
- Average percentage of regulatory affairs budget dedicated to outsourcing by company type
- Outsourcing challenges by category: small companies (mid-size, large, all pharma, medical devices)
- Breakdown of outsourced regulatory affairs activity
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Pharma and Medical Device Regulatory Affairs Report Sample
The following excerpt is taken from Chapter 1, "Integrating Regulatory Affairs with Product Development." For an in-depth look at this topic, including data points and analysts' recommendations, please purchase the full report.
Interact with Key Stakeholders in Product Development
Though technically housed in their respective specialty departments, personnel at Company 25 are organized not by group or function but by project team in a "hub structure." The groups are further organized by business unit, therapeutic area and category within area. As a large company, Company 25 maintains a wide range of products and wants to keep related project teams and personnel close. Therefore, project teams, from the VP down, sit in the same space and near other teams working on products within that therapeutic area. The interviewed executive from Company 25 provided an example: the VP of R&D for a particular product sits with the VP of commercial and marketing, along with representatives from regulatory affairs and new product planning. If the drug is on the market, lifecycle management and any other support personnel necessary work to coordinate objectives, depending on the developmental stage of the product.
The advantages of this structure are simple but effective. Product teams are clearly defined from the beginning of development and continue throughout the drug's life. Responsibilities and resources are clearly allocated. The physical aspect of the setup — the close proximity — facilitates quick communication between coordinating groups. As this executive noted, "We can shout to one another if need be." Moreover, it involves all parties from the beginning of a project. Most importantly, regulatory affairs can guide and prepare a regulatory path from the onset.
This excerpt is taken from Chapter 3, "Regulatory Affairs Staffing and Budgets." A section of the chapter is dedicated to regulatory affairs outsourcing.
Pharma and Medical Device Regulatory Affairs Outsourcing
Surveys and interviews reveal that the largest companies depend on outsourcing to a lesser degree than mid-size and small organizations. Figure 3.35 [figure appears in full report] shows that three quarters of large-company survey respondents keep all of their regulatory activities in-house — only 25% of these industry leaders outsource at least some of their work. Such large organizations boast fully developed infrastructure and expertise; the decision to move work to external partners stems from careful strategic consideration, not necessity. Sheer need tends to be the province of small companies, whose limited resources are taxed by core tasks such as product development and marketing — and who have little money or time to spare on a full complement of other functions.
Mid-size companies, however, report the most regulatory affairs outsourcing. Among survey respondents in this category, 60% of companies outsource at least some work. Interviewees report that, as far as regulatory activity is concerned, these companies utilize models that emphasize the heavy use of strategic sourcing that integrates vendors into specific parts of the regulatory affairs workload.
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