REGULATORY AFFAIRS

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Jenniss Research Regulatory Affairs group works collaboratively with our clients to develop regulatory strategies and solutions to regulatory issues. Our Regulatory Affairs group also prepares submissions that comply with regulatory guidelines.

 

 

Strategies

In today’s competitive landscape, developing a regulatory strategy document (designed with viable options) and a clinical development plan are key. Jenniss Research helps our clients create clinical drug development plans that support successful product registration. Our expertise includes:

  • Analyses of development plans, program objectives, and data to develop both tactical and strategic approaches 
  • Pre-IND Meetings
  • End-of-Phase 2 (EOP2) Meetings
  • Pre-NDA Meetings
  • Other Type C Meetings
  • Analysis of trends, regulations, and guidelines that may impact the preferred drug development approach
  • Gap analyses

 

 

Regulatory Applications

Jenniss Research works with clients to incorporate their strategies within regulatory submissions, and prepares, manages, and submits regulatory documents including:

  • BLAs and NDAs in eCTD format
  • Response to FDA questions during application review
  • Initial IND Applications and IND Amendments
  • Safety Reports and Updates
  • Annual Reports
  • Requests for Special Protocol Assessment (SPA) 
  • FDA Meeting Briefing Packages
  • Orphan Drug Designation Requests
  • Requests for Fast-Track Designation, Priority Review (and other types of applications for accelerated review)

 

 

Interface with Regulatory Agencies

When obtaining guidance from regulatory agencies, Jenniss Research can perform the following tasks:

  • Prepare clients for regulatory meetings 
  • Develop questions/issues and strategic regulatory responses
  • Run mock meetings
  • Create presentations 
  • Contact regulatory agencies and write meeting minutes.  
  • Prepare 15-day safety reports
  • Help resolve clinical holds
  • Lead and facilitate meetings with the FDA
  • Represent our clients at meetings with regulatory agencies

 

 

Regulatory Project Management

Intelligent and well maintained interdisciplinary project timelines are essential for all successful applications. Jenniss Research Regulatory Project Managers generate and manage timelines to ensure key milestones are met. In addition, we lead interdisciplinary teams through the marketing application process.

 

 

Regulatory Operations

The Regulatory Operations staff at Jenniss Research focus on completing high-quality submissions that meet regulatory guidelines and our high standards within the timelines. Jenniss Research’s expertise includes the following:

  • Application File maintenance:  Organize, submit, and maintain regulatory files (e.g., IND and NDA files)
  • Track, store, and retrieve regulatory documents 
  • Document production
  • Format documents for electronic submissions according to ICH and FDA guidelines
  • Prepare individual documents for electronic submission (e.g., eCTD format, including creation of pdf files, bookmarking, and hyperlinking)
  • Hands Free Clinicaltrials.gov service – Jenniss Research will upload and maintain study information on Clinicaltrials.gov using our proprietary ClinicalTrials.Done™ process.