Clinical & Non-Clinical Services

Module 2.4
Preclinical or Non-clinical Overview

We deliver a clear and concise Preclinical Overview, summarizing pharmacological, pharmacokinetic, and toxicological findings. This section contextualizes non-clinical data to highlight relevance to human risk, aiding in the successful progression of your product from lab to clinic.

Module 2.5
Clinical Overview

Our Clinical Overview service provides expert-driven analysis and interpretation of clinical data. This narrative bridges clinical findings with therapeutic rationale and risk-benefit assessment, ensuring alignment with regulatory expectations for submissions such as the Common Technical Document (CTD).

Module 2.6
Preclinical or Non-Clinical Summary

We support in writing a scientifically robust, EMA-compliant summary of pharmacology, pharmacokinetics, and toxicology—distilling complex preclinical data into a compelling safety dossier.

Module 2.7
Clinical Summary

We provides expert support in writing a structured, data-driven synopsis of clinical pharmacology, efficacy, and safety—presented in a format that aligns with EMA’s and other regulatory bodies expectations for transparent and scientifically sound submissions.

Risk Management Plan

At RGInsight , we provide expert Risk Management Plan (RMP) writing services designed to support your product’s safety throughout its lifecycle. An effective RMP is critical to meeting regulatory requirements and safeguarding patient health by proactively managing potential risks.

Our integrated approach ensures high-quality data, regulatory compliance, and efficient timelines, all tailored to meet global submission standards.