GMP Product Development

Product Development Team

 

  • Frontage has a strong team of product development scientists in the US and China with over 60 scientists working in analytical, formulations, engineering and organic chemistry disciplines.
  • The New Product Development Center in Beijing brings key research activities close to the client, with:
    • State-of-the-art, small scale process equipment used to model processes
    • The ability to manufacture GMP materials for clinical studies

Our leadership team has developed and commercialized generic products for the US and EU markets.

These include:

 

  • Sterile products (liquid injectables, suspensions, lyophilized powders, ophthalmics, nasal sprays)
  • Oral Solid Dose products (immediate release, delayed and controlled release tablets and capsules)
  • Topical products

Frontage operates R&D activities using new Quality by Design requirements (ICH Q8 guideline).

 

We also provide Technical Transfer support.

 

  • We are experienced in scale up and submission batch requirements
  • We will guide the scale up activities with FDA-compliant protocols and support FDA & EU Pre-Approval Inspections