Bringing innovative therapies and medical technologies to patients requires more than strong science—it demands navigating a complex, evolving global regulatory landscape. At Premier, we deliver end-to-end regulatory services, guiding you from early development through submission and approval, with a focus on speed, strategy, and compliance.

Whether you need fractional FTE support, interim regulatory affairs staffing, or a fully outsourced regulatory department, our experts act as a seamless extension of your team—tailoring solutions to your program’s size, scope, and stage.

With regulatory professionals across the U.S., Canada, and the EU, we offer localized insight backed by global alignment. Our team has deep experience preparing and reviewing submission materials, securing expedited development designations, and engaging effectively with health authorities.

• Regulatory strategy and gap assessments
• Submission planning and execution
• Expedited designation requests
• Health authority communications
• Technical and quality documentation review
• Market authorization and post-approval support

From small molecules and biologics to medical devices, we align your program with evolving global requirements to reduce risk, accelerate development, and support long-term success.

Health Authority Interactions and Engagement

We guide you through strategic interactions with regulatory agencies and health authorities—from early scientific advice to major milestone meetings—ensuring your development plans are clear, compliant, and compelling. We’ll help you to ask the right questions, present your data effectively, and make the most of each interaction.

Our Services Include:

• Meeting strategy, preparation, and participation
• Briefing book development and submission logistics
• Global regulatory guidance (FDA, EMA, Health Canada, and others)
• Device-specific engagement: FDA Q-Submissions, EU/UK notified body submissions, classification discussions

Key Meetings Types We Support:

• Pre-IND, INTERACT, and Pre-Submission Meetings
• End-of-Phase (EOP1, EOP2), Pre-NDA/BLA, and Advisory Committee Meetings
• Type A, B, C, D Meetings (U.S.) and equivalent EU/Canadian engagements

Regulatory Submission Development and Maintenance

Our team manages every aspect of regulatory submissions and lifecycle maintenance across a variety of product types:

Pharmaceutical & Biologic Submissions:

• INDs, NDAs, ANDAs
• BLAs and related biologics documentation
• eCTD preparation, formatting, and submission
• IMPDs, MAAs, and CTAs (EU and Canada)
• Pediatric Study Plans (iPSPs, PIPs)
• Special Protocol Assessments (SPAs)

Medical Device & Diagnostic Submissions:

• 510(k), De Novo, PMA, and IDE submissions (FDA)
• EU Technical Files and UK Design Dossiers for CE/UKCA marking
• Regulatory documentation gap analyses and QMS alignment
• Representation services: U.S. FDA Agent, EU Authorized Representative, UK Responsible Person

Expedited and Special Designation Support

We help you unlock accelerated pathways to approval by identifying and securing the appropriate designations for your product and market. We support:

• Fast Track, Breakthrough Therapy, and Priority Review (FDA)
• Orphan Drug Designations (FDA, EMA, Health Canada)
• Rare Pediatric Disease and QIDP Designations (U.S.)
• Equivalent expedited programs in Canada and the EU
• Strategic support for medical devices eligible for FDA Breakthrough Device Designation or EU innovation pathways

Why Choose Premier?

Every product—and every regulatory journey—is unique. That’s why our team takes the time to understand your program, identify key risks and opportunities, and deliver proactive, strategic regulatory support across your entire development lifecycle. Let Premier be your regulatory partner—from concept to market.

Contact Premier today to meet with our regulatory experts and discuss a customized strategy to move your program forward with clarity, confidence, and compliance.