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 a variety of generic products for the US and EU markets:
- 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
We operate 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