1. Regulatory Query Statistical Consulting
PHARMA-STATS provides end-to-end statistical consulting for regulatory queries, covering analytical and clinical domains with methodologically sound, submission-ready responses.
Our consulting covers a wide range of regulatory challenges across dissolution similarity (bootstrapping), analytical method evaluation, clinical trial methodologies, bioequivalence, population bioequivalence, ensuring alignment with current regulatory expectations.
We support sponsors in navigating complex statistical queries with clear, methodologically sound, and submission-ready responses.
2. In-Vitro Convolution Modelling (IVIVR)
At PHARMA-STATS we use mathematical models to convert in-vitro dissolution data into a form that mimics in-vivo pharmacokinetics, effectively allowing researchers to understand absorption rates, bioavailability, and overall drug efficacy without the need for early-stage human trials.Â
3. Dissolution Similarity (Bootstrapping)
Choose PHARMA-STATS for dissolution similarity analysis that combines statistical rigor with proven regulatory success, ensuring your drug formulations are optimized and ready for approval for biowaivers.Â
4. Population Bioequivalence Analysis
Purpose:
PHARMA-STATS ensures that all PBE analyses strictly adhere to these OGD guidelines, providing accurate, validated results that support the regulatory approval process. This rigorous approach ensures the safety, efficacy, and consistency of generic drugs, thereby facilitating their acceptance by regulatory agencies.
5. Peer Review of Previous Studies for a Successful New Trial
By partnering with PHARMA-STATS for peer review, you gain a trusted ally that helps turn past failures into stepping stones for success, ensuring your future clinical trials or bioequivalence studies are scientifically robust and ready for regulatory approval.Â
