Product Development
Gorbec provides complete formulation development services for topical and oral products including liquid, semisolid and solid dosage forms with an emphasis on guiding your product through the ANDA, 510(k), 505(b)(1) and 505(b)(2) NDA submission process. Formulation services include:
- Pre-formulation and proof-of-concept studies
- Formulation design and optimization
- Lab and pilot scale manufacturing
- Development and validation of manufacturing and cleaning processes
- Stability studies (accelerated, real time, photo)
- Electronic FDA submissions