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
Analytical Services
To compliment of our product development team, we have a fully staffed analytical R&D department equipped with all the necessary tools and expertise to support any analytical needs.
- Preformulation
- De-formulation of existing products
- Stability Indicating Method Development and Validation
- Residual solvent and related compound testing
- Dissolution and Disintegration
- Physical characterization testing for solid and semi-solid dosage forms
Quality Services
Gorbec has a three tier quality department comprised of Quality Control, Quality Assurance, and Regulatory Affairs.
- Maintains a state of quality and control throughout the facility at all times
- Approves all SOPs and controlled documents
- Interfaces with FDA
- Raw material and finished goods qualification and release
- Handles any investigations and provides corrective action
GMP Contract Manufacturing
Gorbec offers its pilot scale manufacturing capabilities on a contract basis. We support in-house product development through to commercial manufacturing, as well as the tech-transfer process.
- Process and cleaning validation
- In-house USP water system
- Solid dose manufacturing capabilities including tablets and capsules
- Solution, Cream, Ointment, and Gel products supported by validated filling systems
- Class 100,000 modular processing rooms
- DEA Licensed to handle Schedule III-V finished goods manufacturing
Development > Manufacturing > Testing > Quality