Forward thinking regulatory policy strategy and implementation can have a significant positive impact on medical technology development across the product life cycle. FaegreBD Consulting's integrated services help fuel medical innovation by identifying new opportunities, increasing speed to market, decreasing cost, and leading to enhanced product success and profitability.

Our professionals have extensive experience in interacting with the Food and Drug Administration (FDA) and other U.S. and European regulatory agencies on both the policy and technical levels. We advocate for changes that impact the health and life sciences industry and apply technical expertise to represent our clients' interests across the product life cycle from early phase development to postmarket programs. We develop Risk Evaluation and Mitigation Strategies (REMS) and assist in preparing annual reports after approval. When problems with compliance or enforcement emerge, we offer proven expertise and develop plans to implement practical corrective strategies.

FaegreBD Consulting helps clients shape regulatory agendas across a wide range of federal agencies and effectively navigate rule-making processes. Our team's long-standing relationships with members of Congress and their staffs help navigate the bureaucracy and solve problems quickly and efficiently.

Food and Drug Administration (FDA) Interfaces

FDA actions and interactions can make — or break — a product and its innovator. Our health and life sciences team has significant experience representing clients before the FDA and can help companies anticipate changes and comply with agency regulations. We provide comprehensive product life cycle management assistance for pharmaceutical and biopharmaceutical products, including drug development and regulatory strategies, compliance with FDA regulations/guidances and related development performance. We have formed an integrated team of well-respected reimbursement FDA media and federal relations experts experienced at meeting a broad range of client needs.

Throughout the entire device or product life cycle, FaegreBD Consulting offers proven approaches to position companies for regulatory leadership and compliance. Our professionals facilitate development, submission and review processes for worldwide product approval labeling, commercialization and proactive drug safety/risk management. We continually monitor the ongoing changes in FDA and other regulatory requirements to best advise you on course corrections that can affect your products.

Services

Some of the specific regulatory consulting services we provide include:

Phase I Early Stage Development Support

This phase includes formulating overall proactive approval and compliance strategies, Investigational New Drug (IND) and Investigational Device Exemption (IDE) submission, regulatory planning and guidance, dose finding, proof-of-concept studies and target product profile development.

Phase II Planning

This phase includes preparation to address regulatory and reimbursement considerations. We provide:

• Extensive training and preparation for FDA interactions;
• Facilitation of simulated (i.e., "mock") and actual FDA  milestone meetings (such as end of Phase II); and
• Revisions in overall regulatory strategy and pre-clinical and clinical research plans.

Phase III Late Phase Development

This phase includes regulatory strategy for safety, efficacy, quality and outcomes aspects of registration, trials, data, safety monitoring board services, and Risk Evaluation and Mitigation Strategies (REMS) planning, as well as simulated Special Protocol Assessments (SPA) and pre-New Drug Application interactions.

New Drug Development Application (NDA)

• Pre-submission consultation, including dossier and submission cover letter preparation, simulated (i.e., "mock") submission review and coordination benefit/risk (REMS and other drug safety positioning).
• Submission and filing interaction consultation.
• Review process advice, including preparations for advisory committee hearing (mock sessions simulation advance Q&A development), preparation for label negotiations and special population (e.g. extremes of age organ impairment other) positioning.
• Approval process, including launch/promotional material review for compliance/labeling consistency REMS plans.
• Post-approval support such as REMS, post approval commitments, and annual reports.
• Post approval support assessments and advocacy.
• Issues management/crisis management — pre and post approval such as label changes, enforcement actions by FDA, safety issues, etc.
• Due diligence and portfolio review processes for pharma clients and venture capital firms.
• Policy/advocacy including Prescription Drug User Fee Act (PDUFA) and similar legislative interests which intersect with FDA oversight.