We look forward to develop your new product or extend the life cycle of your existing product right from R&D feasibility assessment through commercial validation and full manufacturing. Our experienced in-house R&D team can assist you to leverage your ideas and plans to make your product launch a success.
The technical support we provide our customers includes the following:
- Instrumented tablet studies
- Stability studies
- Formulation assistance
- Taste Panel Evaluations
- DMF documentation
- Technical Service Reports
Quality by Design (QbD), approach for new drug product development based on ICH Q8R standards.
QbD process is managed internally through the following key phases:
Target Product Profile (TPP) – client input that accurately describes the end product and its ideal requirements
Determine Critical Quality Attributes (CQA’s)
Link raw material attributes & process parameters to CQA’s and perform Risk Assessment
Development of a Design Space
Design & Implement a Control Strategy
Manage Product Lifecycle Opportunities, including Continual Improvement