STABILITY LEADS TO PROGRESS
Stability is an essential quality attribute of active substances and medicinal products and, therefore, stability testing is a crucial component of the development process.
3R PHARMA CONSULTING provides scientific/technical advice and sustainable solutions based on long-term experience and expertise.
What we offer:
- Strategic advice concerning a science-based design of stability studies meeting regulatory requirements, in particular ICH Guidelines Q1A(R2), B, D, and E;
- Development of cost-effective stability protocols for global markets, including Climatic Zone IVA and B;
- Advice on Bracketing and Matrixing of stability studies in order to reduce the number of samples to be tested and thus the cost of the studies;
- Evaluation and statistical analysis of data using MATLAB (from MathWorks);
- Generation of stability reports and summaries;
- Advice concerning temperature monitored and controlled shipment and storage of pharmaceutical products (Good Distribution Practice / Good Storage Practice / Cool Chain Distribution);
- Calculation and assessment of the impact of temperature excursions on the product during shipment and storage;
- Investigation of trends;
- Assessment of Out of Specification (OOS) results.