Pre-Clinical and Clinical Development


We offer the following development services:

  • Formulating pharmaceutical product development programs and plans
  • Legal strategies and patent development
  • Clinical protocol development and study designs for phases I through IV
  • BA and BE clinical approaches and protocol development
  • PK / PD modeling and simulation
  • Medical writing
  • Biostatistical and statistical approaches
  • Formulation and process evaluation
  • Small molecule synthesis to macromolecule bio-processing
  • Solutions, solids, suspensions, aerosols, transdermals, parenterals
  • Analytical / Bioanalytical approaches
  • Validation plans
  • Quality systems
  • IND preparation and submission
  • Package insert preparation
    Organization and preparations for FDA – Sponsor Meetings including:

  • Pre-IND Meetings
  • End of Phase II Meetings
  • Pre-NDA Meetings
  • Other type A, B, and C meetings, regulatory submissions and responses
  • Construction of Standard Operating Procedures (SOPs) for product development and clinical research
  • Review business practices, opportunities and products for licensing, development, and due diligence prior to acquisition or public offering