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3R PHARMA CONSULTING

Regulatory and Drug Development Advisory Service

More info about 3R PHARMA CONSULTING

Evaluation of Stability Studies

3R PHARMA CONSULTING

Stability testing is a vital component of the development process in pharmaceuticals.

3R PHARMA CONSULTING provides scientific/technical advice and sustainable solutions based on long-term experience and expertise.

The company offers:

  • 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, thereby decreasing the cost of the studies
  • Evaluation and statistical analysis of data
  • Stability reports and summaries
  • Advice relating to temperature monitored and controlled shipment, as well as storage of pharmaceutical products meeting good distribution practice (GDP), good storage practice (GSP) and cool chain distribution standards
  • 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
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