Catalyst provides a full range of Regulatory services to established and “emerging” pharmaceutical companies. These include Regulatory Strategy, Liaison and Operations/submissions


In each case, Catalyst provided a strategist with extensive experience with the product type (small molecule, biologic, cellular therapy) and the therapeutic area (CNS, Oncology, Inflammation, etc) to provide regulatory leadership

 

Case Study #1

Small Company “A”
Location: US West Coast
Funding: Venture capital
Employees: ~5
Compounds: 1

Activities supported:

  • Preparation and submission of 1 new IND (eCTD format)
  • Maintenance of 2 INDs in eCTD format (small molecule for inflammatory conditions)
  • Regulatory Strategy support (no in-house staff)
  • Authorized Agent – point of contact for all correspondence with FDA

     

Case Study #3

Small Company “M”
Location: US Midwest
Funding: Venture capital/Angel
Employees: ~6
Compounds: 2

Activities supported:

  • Preparation and submission of 2 new INDs
  • Maintenance of 3 INDs (small molecules for metabolic/CNS disorders)
  • Regulatory Strategy support in collaboration with client regulatory staff (n=1)
  • Authorized Agent – point of contact for all correspondence with FDA

Case Study #5

Mid-size European Company “A”
Location: Central Europe
Funding: Publicly Traded
Employees: ~100
Compounds: >10

Activities supported:

  • US Authorized Agent – point of contact for all correspondence with FDA
  • Preparation and leadership for 3 pre-IND meetings (novel formulations of marketed small molecules for CNS/Oncology)
  • Preparation and submission of SPA for Phase III registration studies
  • Regulatory Strategy support in collaboration with client in-house EU regulatory staff

Case Study #2

Mid-size European Company “MS”
Location: Central Europe
Funding: Publicly Traded
Employees: ~80
Compounds: 6

Activities supported:

  • US Authorized Agent – point of contact for all correspondence with FDA
  • Preparation and leadership for pre-IND meeting (Biologic for Oncology)
  • Preparation and submission of 1 new IND in eCTD format with partner submission vendor
  • Maintenance of 2 INDs
  • Regulatory Strategy support in collaboration with client EU regulatory staff

Case Study #4

Small US Company “C”
Location: US East Coast
Funding: Venture Capital
Employees: ~5
Compounds: 3

Activities supported:

  • Authorized Agent – point of contact for all correspondence with FDA
  • Maintenance of IND for phase II compound (Cellular therapy biologic for GI disorder)
  • Strategic evaluation of 4 potential new indications to determine regulatory requirements
  • Comprehensive Regulatory Strategy support (no in-house staff)