strategy

Meet your milestones

Strategy

Regardless of project or program scale, Therapeutics Inc. will provide a turn-key solution from concept through FDA approval.

Every project is initiated with a face-to-face meeting to define your overall program development strategy.  We establish a dedicated team, schedule regular meetings and identify key contacts with specific knowledge in your product area. Your project will be thoughtfully planned and precisely executed to facilitate regulatory approval.

Nonclinical

  • Formulate proof of concept studies
  • Design pharmacology/toxicology programs
  • Design formulation and analytical chemistry studies

Clinical

  • Clinical strategy
  • Protocol design and implementation
  • Network of expert clinical trial investigators

Regulatory

  • Central to development planning process
  • No shortcuts taken
  • Alternate pathways/creative approaches to satisfy requirements

ConceptToApproval

Let us lead your dermatology product development program through the complex maze of non-clinical, clinical and regulatory hurdles to an FDA approval.Get started