Pharmaceutical and Medical Device Regulatory Affairs
Pharmaceutical and Medical Device Regulatory Affairs
Guarantee smooth approvals with a top-flight regulatory affairs team
Regulatory teams save time and money as they drive commercial and development goals forward. Build healthy relationships with - and receive clear direction from - regulatory agencies through early, consistent communication.
Immediately draw upon the expertise of more than 50 leading companies across the life sciences spectrum. Whether you're part of a large pharma or a medical device firm, you'll find pioneering methods for adapting to the current regulatory climate. Empower regulatory affairs in these main areas:
Structure
Gain greater influence in the design, planning and direction of product development. Organize your team to solve problems more quickly - choose from innovative regulatory affairs structure models.
Communication
Consult timeline and frequency metrics to adjust your communication tactics with regulators. Along the way, explore novel strategies for engaging regulatory agencies - and absorb tailored recommendations specific to pharma and medical device firms.
Budgets and Staffing
Equip your team with the resources to generate the best possible product support. Spending and staffing benchmarks will guide you through resource allocation. Also, track outsourced activities and funding to understand why teams use vendors - and how much they spend on them.
Sample Content from the Report
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.
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.
Companies Featured in this Report
* Abbott Labs
* Alcon Labs
* Allergan
* AngioDynamics
* Archimedes Pharma
* Ariston Pharma
* AstraZeneca
* Aritech
* Bausch & Lomb
* Becton Dickinson
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