Services - BEMONIT

Complete Bioequivalence study management – From Drug development to Regulatory submission

Selection of CRO

BE study design inputs

Sample size calculation and finalization

Protocol Development and Review

Literature Review support

Monitoring Bioanalysis –MD/MV, protocol compliance, ISR and repeat analysis

Complete Module 5 Report Review

General biowaiver / BCS based biowaiver requirements

Risk Analysis in bioequivalence decisions / Failure mode Analysis

GCP / GLP training, etc.

CRO Audit / Feasibility check

PK analysis evaluation

Blood sampling points finalization

BE study / CT studies Monitoring

RLD Identification and Sourcing

Regulatory guidance requirements for the international regulatory body

Bio-relevant medium selection / Formulation dissolution review

Population Bioequivalence study Analysis (PBE)

IVIVC Analysis

Analysis of the post-pilot BE research and next steps for a crucial BE choice

Clinical / Justification report write-up