Formulation Development

Tergus is a one-stop solution for your topical formulation development needs

You have an API or NCE in your pipeline that you need to get to market fast. Tergus is the market leader in topical formulation development. We have the expertise to help you create a successful topical formulation that reaches its target, maintains efficacy and succeeds. From development plan creation to reproducible and scalable formulations that meet Phase III requirements, we can ensure the fastest path to market.

Tergus pioneered QbD for semi-solid dosage forms, which helps ensure speed and success for clients. Our impeccable track record of more than 20 years of client service speaks for itself. We are unique in our ability to handle challenging products, from hydrophobic APIs to biologics.

Services Include:

  • Development Plan Creation
  • Entire pre-clinical development including IND-toxicology support
  • Selection of clinical candidates using disease models and in vivo studies
  • Reproducible and scalable formulations to meet Phase III requirements
  • Evaluation of innovative platforms and technologies
  • Expertise in developing non-infringing, novel patented formulations
  • GLP/GMP Analytical and Drug Development Laboratories
  • Target Product Profile Development
    • Formulation Development and Optimization
    • Novel Formulation Platform Development
    • IP Review and Risk Mitigation Strategy Development
    • Guidance on Formulation Platforms and IP Optimization
    • Specialty / Platform Development Services
    • Analytical Services
    • Coordination with in vitro and in vivo studies
  • Program Management Leadership
  • Logistics Leadership
  • Scale-up and Technology Transfer Oversight
  • CMC, Clinical & Regulatory Consulting
  • Disease Model Development
  • Clinical Strategy Development
  • Development Plan Creation to ensure fastest path to in vivo or Clinical PoC studies