Regulatory Policy Services
Regulatory policy is an essential component of the FDA regulatory landscape – it helps shape how regulators make decisions about the development, approval, and marketing of drugs, biological products, medical devices, and combination products. These policy decisions determine the feasibility of the development and use of new technologies and directly affect patient access to medical products.
Greenleaf’s regulatory policy services are designed to support the needs of large and small clients as they navigate FDA regulations and regulatory policies. The firm’s team of experts works cross-functionally to assist pharmaceutical and biotechnology companies, medical device manufacturers, patient groups, trade associations, and other stakeholders in communicating effectively about FDA regulatory policy issues and in understanding, implementing, and complying with the FDA’s regulatory programs.
Regulatory Policy Services Team
Greenleaf’s Regulatory Policy Services Team offers a rare blend of perspectives developed as leaders in both the public and private sectors. This wealth of experience equips clients with a trusted partner when seeking guidance on implementing, complying with, and communicating about FDA regulatory policy.
Our Regulatory Policy Services
Greenleaf’s well-regarded professionals have each spent decades working in leadership roles at regulatory agencies and within regulated industry. The Regulatory Policy Services Team provides advice and recommendations based on extensive institutional knowledge of the FDA’s overarching regulatory approach, as well as deep and granular expertise regarding FDA regulation of medical product types across the product lifecycle.
Areas of Expertise
Drawing on our unparalleled knowledge and experience, Greenleaf supports the needs of large and small clients to understand and address FDA regulations and regulatory policies that affect the development and lifecycle of a medical product and that can improve access to products for patients. Our areas of expertise:
- Insight into FDA regulatory policy, including novel programs
- Regulatory intelligence and scientific policy
- Effective communication on regulatory policy issues
- Product designations and access to expedited programs
- Regulatory issues arising both pre and post market
- Building client capacity and understanding of regulatory policy issues
Clients utilize Greenleaf’s depth and breadth of knowledge to build their capacity to implement, comply with, and communicate about FDA regulatory policy. Our capabilities include:
- Engaging with stakeholders and leveraging alliances to design and implement strategies that will advance regulatory policy in the public space.
- Supporting stakeholders in user fee negotiations and assess the impact of user fee agreements, statutory changes, regulatory initiatives, and other policy developments on clients, patients, and the broader regulatory landscape.
- Providing strategic regulatory guidance for sponsors seeking access to FDA programs and designations, including orphan drug, breakthrough therapy, RMAT, and other expedited pathways.
- Helping clients navigate the emerging regulatory landscape and ways that novel tools and approaches can optimally be incorporated into development programs.
- Supplying strategic regulatory guidance that enables sponsors to understand and respond to pediatric written requests, the scope of exclusive approval, and determinations related to priority review vouchers.
- Addressing policy issues related to development programs, combination products, submissions for marketing authorization, and the postapproval phase.
- Assisting clients with structuring their regulatory policy capabilities to effectively advance their specific priorities.
Digital Health Services
Greenleaf experts provide guidance to clients developing, commercializing, utilizing, and investing in innovative digital health technologies as they navigate the evolving landscape of FDA digital health requirements.