Services

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

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

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

Read about ... your consultant

"Make the Pharma Regulatory Connection"

Contact

Phone: (860) 461-5487