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
      •  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:

CE3 Inc.

Read about ...  your consultant

"Make the Pharma Regulatory Connection"


Phone: (860) 461-5487