Services

Your resource for Regulatory Expertise and Experience:

  • Your Principal Consultant, Nancy C. Motola, Ph.D., RAC, has more than 30 years of experience in emerging and established pharmaceutical and biotechnology companies.
  • Offering regulatory expertise spanning discovery, development, registration, commercialization and lifecycle management of Drugs and Biologics in a variety of therapeutic areas

Providing regulatory services to meet your objectives:

  • Strategic planning for / and regulatory submissions, e.g.
    • INDs and related activities
      Original INDs
      Fast Track Applications
      Special Protocol Assessments
      FDA Liaison Services
      FDA Meetings
    • NDA/BLA/ANDA
      505(b)(1) and/or 505(b)(2)
      SNDA/SBLA
      Drug Master File (DMF) Support
      FDA Meetings
    • FDA Meetings
      Pre-IND, pre-NDA/BLA, End of Phase 2, Type A-C
      Advisory Committee Meeting Support
  • CMC & Regulatory Compliance support and strategies: pre and post-approval
  • Product Life-Cycle Regulatory Support
    New indications & line extensions
    Post-approval manufacturing and maintenance
    Advertising & promotional material review
  • Business Development Support
    Regulatory Intelligence
    Regulatory Due Diligence
    Participation on partnership teams

Recent Projects:

  • VP RA for start-up of a new pharma company (2009-2014).  Accomplishments include:
    3 pre-NDA meetings for first product
    Leadership for creation of e-CTD/NDA for company's first product, to be submitted for FDA
      review/approval in 2014
    writing/contribution to the Private Placement Memorandum (PPM)
    Participation in "deal" road shows for venture capital/investment funding and corporate partnerships
  • Due diligence for a large global pharma company regarding potential licensing of an Asian drug candidate
  • Partnership with an Asian CSO as an authorized RA representative for client US INDs, as well as Scientific Advisory Board
  • Several pre-IND meetings with FDA, leading to original IND Application submissions

Current clients:

New Haven Pharmaceuticals CE3 Inc.
Efficient Pharma Management Co Aldea Pharmaceuticals

Read about ...  your consultant

“Make the Pharma Regulatory Connection”


Contact
email Pharma Regulatory Connection
Phone: (860) 461-5487