Catalyst provides highly qualified Regulatory Strategists to fill resource “gaps” at mid-size and large pharmaceutical companies.  We have successfully delivered services several “top 10” companies, all of which have been long-term repeat customers.  We provide skilled strategists to support both marketed products and development activities.  In most cases, our strategists have been designated as the Regulatory Leader for their assigned compounds. 

Catalyst has an extensive pool of highly qualified strategists with experience working in “large pharma” environments.  Generally, these strategists work remotely but within the clients infrastructure (Regulatory Operations functions, Document Management systems, proprietary regulatory systems, etc).  Typically the client provides a laptop to the consultant to access the proprietary/confidential systems and to facilitate communication with the teams they are supporting.

Case Study #1

Top 5 Multi-National Pharmaceutical Company
Primary Locations: US East Coast and Central Europe
Continuous client since: 2008
FTEs Assigned: Up to 3 concurrently

Activities supported:

  • Strategic leadership for numerous projects in early development portfolio
  • Management of Global Labeling for marketed and late-stage investigational agents
  • Labeling compliance evaluation for all US Package Inserts
  • Global Regulatory Lead for key marketed product.  Responsible for maintenance and line extension activities in Europe, Asia, Middle East/Africa and Latin America.
  • Support of development projects during maternity leave

Case Study #3

Top 5 Multi-National Pharmaceutical Company
Primary Locations: US East Coast, US West Coast and Central Europe
Continuous client since: 2011
FTEs Assigned: Up to 4 concurrently

Activities supported:

  • Regulatory Strategic support for mid-stage development compounds in CNS therapeutic area during extended maternity leave
  • Regulatory Strategic support for multiple indications for high-profile late-stage development compound (metabolic)
  • Regulatory Strategic support for preparation and submission of new US IND
  • Leadership for numerous FDA meetings

Case Study #2

Subsidiary of top 5 Multi-National Pharmaceutical Company
Primary Location: US South
Continuous client since: 2013
FTEs Assigned: Up to 9 concurrently

Activities supported:

  • Regulatory Advertising and Promotion support for Pharmaceuticals, Medical Devices and OTC products
  • Regulatory Strategic support for new marketed product – supporting registration in 25 markets following initial approval in Europe
  • Regulatory Strategic support for investigational agents for a variety of indications
  • Regulatory writing support for preparation of expert reports
  • etc.

Case Study #4

Top 20 Multi-National Pharmaceutical Company
Primary Locations: US East Coast and Central Europe
Continuous client since: 2010
FTEs Assigned: Up to 3 concurrently

Activities supported:

  • Regulatory CMC support to expand registration into many secondary markets
  • Regulatory CMC support for marketed product maintenance activities (US/EU/ROW)
  • Preparation of Annual Reports
  • etc