General Consulting Services
We can lead you from early development to approval including:

  • Regulatory consulting support for all submission types
  • Project planning and cost/budget development
  • Competitive regulatory intelligence
  • Electronic submission design
  • Assistance with FDA requests including issues and inspections
  • Non-clinical and clinical study design
  • Training and other educational support for regulatory requirements, drug and device development pathways and more

Rx-to-OTC Switch Analysis
  • ARC can analyze your product portfolio to help identify strong candidates for Rx-to-OTC switch
  • Develop a detailed switch project plan with a budget
  • Lead or assist in the preparation for meetings with FDA regarding your Rx-to-OTC switch project
  • Rx-to-OTC switch study design
  • Drug Facts Box and other labeling development
  • Label Comprehension, Self-Selection and Actual Use study planning
  • In-depth safety analysis
  • Advisory Committee preparation



FDA Meeting Preparation
FDA meetings are critical steps in the product development process.  We can help make sure your team is fully prepared.  Our team can:
  • Walk you through every step, for in-person meetings and teleconferences
  • Write or review the meeting briefing document
  • Conduct a mock-meeting to ensure your team is ready
  • Lead the actual FDA meeting if so desired
Submission Planning & Authoring
From scratch to submission, our team will create a road map to clearly depict what is needed to gain FDA approval of your drug or device.  Our services in this area include:
  • Support for all types including NDA, PMA, 510(k), IND and IDE original submissions, amendments and supplements.
  • Project plan development which fully outlines what information is
    required for each aspect of the submission.
  • Technical writing and editing
  • eCTD backbone creation
  • Project management services
  • Publishing and final review
Advertising and Promotional Material Review
  • Fast and thorough review of advertising and promotional materials for compliance with FDA requirements
  • Assistance in the development of aggressive yet "on-label" marketing claims
  • Risk assessment of existing marketing materials
  • Process development and improvement - we can thoroughly evaluate and optimize your existing review process
  • Material Types We Review - print and web/internet advertisements,  broadcast advertisements (TV or radio commercials and other spots), billboards (mobile and fixed), leave behinds, sales aids, direct mailers, Managed Care materials, press releases, labeling, electronic sales aids (iPad and other), Advisory Board materials, co-pay and other rebate cards, speaker presentations/decks, copy review, and much more
Training
ARC is the industry leader in providing low-cost on site regulatory affairs training.  Our team will provide a tailored regulatory affairs training program to fit your needs.  Examples include:
  • Regulatory Affairs 101 - The basics
  • Medical Devices
  • New Drug Regulations - Drug Development and the FDA
  • Over the Counter Drugs 101 - The Monograph System
  • Cosmetic Regulations - What You Need to Know
  • Rx-to-OTC Switch - Staying Ahead of Changing Times
  • Dietary Supplements