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FDA Regulatory Consulting

Professional Services / Regulatory and Compliance / FDA Regulatory Consulting

Advancing Therapeutics Through Pivotal Regulatory Affairs Approvals

Maintain progress as your program reaches pivotal regulatory stages by engaging our experts to identify, prepare, and submit the appropriate materials to regulators. We provide expert insights on the best pathways forward to ensure adequate funding and technical support. With drug development being such an extensive, detail-oriented process, partnering with world-class regulatory affairs consultants helps safeguard your progress and maintain efficiency.

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Navigating The Investigational New Drug Application Process

The investigational new drug (IND) application is an important milestone in drug development. This presentation will explore the drug development process with specific insights on FDA’s regulations, including an overview of the required content for a successful IND application and recommended interactions with the Agency to ensure success.  

Pharmaceutical Regulatory Affairs Services

Our understanding of the domestic and international regulatory challenges facing biotech and pharmaceutical operations enables our experts to provide comprehensive support across the drug development pipeline.

Regulatory Strategy

Leverage our expertise in drug development for pharmaceuticals, biologics, gene therapies and drug-device combination products. Our team has extensive knowledge in the US and EU regulations.

  • Regulatory Advisory Consulting
  • Gap Analysis
  • Feasibility Assessment
  • CMC Consulting
Designations And Expedited Programs

Determine the best path forward for your therapeutic or device. Our consultants provide insights to guide you through designations that support your program.

  • Orphan Drug Designation and Annual Reports (FDA and EMA)
  • Rare Pediatric Disease Designation
  • Regenerative Medicine Advanced Therapy Designation
  • Qualified Infectious Disease Product Designation
  • Expedited Programs
  • ○ Fast Track Designation
  • ○ Breakthrough Therapy Designation
Interactions With Agency

Be ready for your engagement with regulatory agencies such as the FDA and EMA. From developing regulatory strategy and authoring meeting requests/briefing packages to meeting preparation and attendance, we provide the level of support you need.

  • Formal Meetings with FDA Type A, B, C, D
  • Pre-IND Meeting
  • End of Phase 2 (EOP2) Meeting
  • Pre-NDA Meeting / Pre-BLA Meeting
  • INTERACT Meeting
IND Authoring

Garner in-depth guidance for your regulatory applications, including authoring of regulatory documents and in-house publishing capabilities. Our team of experts provide full writing and publishing support as well as content, QC, and formatting review.

  • Authoring Regulatory Documents
  • Investigational New Drug Application (IND)
  • Biologic License Application (BLA)
  • New Drug Application (NDA)
  • 505(b)(2) NDA Application
eCTD Publishing

Submit your regulatory documents to the FDA Electronic Submission Gateway (ESG) portal with confidence. We support application preparation including document compilation, metadata hyperlinking, lifecycle management, and technical validation.

  • Initial INDs
  • Annual Reports and/or Development Safety Update Reports (DSUR)
  • Meeting Requests and Briefing Packages
  • CMC Amendments and Protocol Amendments
  • Safety Reporting

Regulatory Affairs Resources

FDA Breakthrough Therapy Designation (BTD)

FDA Regenerative Medicine Advanced Therapy Designation (RMAT)

FDA Fast Track Designation (FTD)

Keeping Pace® with Pharma

Discover unique insights across a variety of topics to meet milestones, achieve regulatory compliance, and relieve internal constraints.

Regulatory Affairs Resource Library

Our expert consulting team dives into a variety of regulatory affairs pathways to provide you with a broader scope of the strategies available.

Integrated Laboratory Services  

When your team needs additional support, we are ready to jump in to meet demand. Our diverse range of regulatory experts allows us to aid in a variety of projects and programs.