Ensuring compliance with local and international safety regulations is critical for product approval. GenEvolutioN provides strategic consulting to help companies meet regulatory requirements and optimize testing methodologies.

• Regulatory Compliance → Guidance on REACH, CLP, FDA, EMA and OECD safety regulations.
• Testing Strategy Development → Assistance in designing in-vitro and in-vivo safety testing plans.
• In-Silico Evaluation → Use of QSAR toolboxes to predict toxicological risks and streamline assessments.

Our team ensures regulatory readiness and helps businesses stay compliant with evolving safety standards.

Nitrosamines have raised significant concerns in the pharmaceutical industry due to their potential carcinogenic effects.

• Hazard identification → Documentation evaluation on the risk of presence of nitrosamines precursors and prediction of the pathways for N-nitroso compound formation
• Risk analysis → In silico estimation (CPCA) and in vitro confirmation (Ames, MLA, MoA) of Acceptable Intake
• Confirmatory testing -> Method development and validation for multi batch testing
• Risk Control Strategy -> Evaluation of confirmatory testing, benefit/risk assessment and definition of the risk mitigation plan (CAPA plan)

As the pharmaceutical industry faces increasing scrutiny regarding nitrosamines, GenEvolutioN is committed to leading the charge in risk management solutions.

A robust risk assessment strategy is crucial for ensuring the safety of chemical substances and minimizing regulatory hurdles.

• Hazard & Exposure Risk Assessment → Evaluating toxicity, environmental impact, and exposure scenarios.
• Data Interpretation & Validation → Analysis of in-vitro and in-vivo test results for regulatory submissions.

With our scientific expertise and analytical tools, we help companies understand and mitigate chemical safety risks.

Accurate documentation and knowledge-sharing are key components of regulatory success. GenEvolutioN assists in report preparation, compliance documentation, and industry training.

• Regulatory Documentation & Submission Support → Assistance in compiling reports that align with global safety standards
• Training & Workshops → Custom sessions on toxicology best practices, compliance strategies, and safety assessments.

We ensure that businesses are equipped with comprehensive knowledge and well-structured documentation for successful regulatory approval.