Optimize Your Process, Pharmaceutical Development
Here at GRAM, we optimize our client’s formulation for scale-up to commercialization. Documented processes and dedicated team members support development for small molecule and biologic parenteral dosage forms, including solutions, suspensions, and lyophilized products. Our team optimizes your process to reduce line loss, increase efficiency, and mitigate risk.
Our development processes include:
- Technology transfer
- Quality by design (QbD) methodology
- Analytical method development and validation
- Manufacturing process design, optimization, and scale-up
- Sterilization cycle development
- Labeling and packaging design
- Stability storage and testing
- Regulatory filing support