Program and Regulatory Strategy

Bringing a new therapy to market demands a strategic, integrated approach from concept to clinic. Premier Research helps you shape and administer your program with end-to-end support that spans early product concept evaluation, patient population definition, competitive landscape analysis, regulatory considerations, and strategic program design.

Whether you’re refining your target product profile or preparing for regulatory engagement, our multidisciplinary experts can seamlessly integrate with your team or fully manage your development needs. We help identify market opportunities, assess clinical and commercial viability, and craft tailored development strategies that align with both patient needs and business goals.

Understanding the regulatory landscape is essential to a successful clinical program, and our seasoned specialists maintain active engagement with global health authorities to set your program on a solid foundation for approval. From strategic guidance on development pathways and submission planning to securing expedited designations, we deliver the insights and execution support needed at every step. At Premier Research, we assess the unique opportunities and challenges of your program across scientific, regulatory, and market dimensions — giving you clarity, confidence, and a path forward.

Drug and Device Development Strategy

Drug and Device Development Strategy

• Consulting services aligned with global health authority thinking on drug, biologics, device, and diagnostic development requirements
• Functional services such as acting head of regulatory for start-up companies
• Preparation and review of clinical development plans, protocols, CMC amendments, and response to agency questions

Market Access, New Product, and Commercial Strategy

Market Access, New Product, and Commercial Strategy

• Strategic insights for optimized market positioning
• Clinical, medical, regulatory, and commercial expertise integrated to help you de-risk investment decisions
• Commercial assessments and competitive landscape analysis
• Solutions to maximize your program’s potential throughout development and the commercial lifecycle

Regulatory Affairs, Submissions, and Publishing

Regulatory Affairs, Submissions, and Publishing

• Extensive experience with agency interactions, averaging 75-plus meetings per year
• Publishing and document management experience, including significant work with new drug applications, biologics license applications, marketing authorization applications, medical device and diagnostics approvals/clearances, and rest-of-world submissions
• Preparation for major submissions and agency meetings:
  • Strategic development plans
  • FDA and EU Notified Body meeting preparation
  • IND/IDE and marketing application preparation and submission
  • Orphan drug, breakthrough, and fast-track applications
  • Clinical study design
  • Clinical study reports
  • Global safety database design
  • SAE reporting

Trial Master File Quality Review and Remediation

Trial Master File Quality Review and Remediation

• Comprehensive eTMF review and migration support
• Optimized eTMF strategy for inspection-readiness
• Structured, GCP-based methodology that includes both standard and customized logic checks and strategic remediation

Customized Development Strategies

Customized Development Strategies

From early-phase to late-stage development, Premier’s global product development team leaders synchronize multidisciplinary services, global development expertise, and insight from therapeutic thought leaders to create development strategies custom-fit to your needs.