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!
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….
Review on Outsoruced Statistics behalf of sponsor
Expertise in Regulatory Query
Successive BE/CT Studies
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