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Regulatory Statistical Consultancy
Today, less than 10% of new compounds reach the market. We offer practical formulation development strategies to improve the excellence of submissions. Statisticians are key players in drug research and development, from the initial identification of a chemical right through to the manufacturing and commercialization of pharmaceutical products!
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At PHARMA-STATS we support from formulation development to post regulatory submission level to our sponsors. We have large experience of USFDA, EMEA, MHRA, TGA.
A right process always reinforces the concept….
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Review on Outsoruced Statistics behalf of sponsor | Expertise in Regulatory Query | Successive BE/CT Studies |
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Verification of sample size | Dissolution similarity and statistical method analysis | Convolution analysis on in-vitro data to get successive pilot/pivotal study |
Verification of study design | Sample size, study design, statistical analysis | Review of failed clinical bioequivalence study from dissolution, design to analysis point to turn in next successive submission |
Review of statistical analysis plan | PK/PD clinical end point trial, Clinical trials, In-vitro studies | Review of failed clinical study from design and analysis end points to turn in next successive design |
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