Non-Clinical

CRO selection and management ›

Choosing the right non-clinical contract research organizations (CROs) and managing them properly are essential for ensuring high-quality and reliable data during drug development.

Toxicological Risk Assessment ›

Toxicological risk assessment is vital in drug development because it helps you evaluate the potential hazards of your drug candidate. By identifying and mitigating risks early, you can ensure patient safety and make informed regulatory decisions, supporting the overall success of your drug development process.

Due diligence ›

Due diligence assessment involves a thorough analysis of the product development strategies and data to identify gaps, deficiencies, and risks- ensuring compliance with applicable regulations and industry standards.

Gap assessment ›

Conducting a gap assessment of pre-approval regulatory files is important to ensure regulatory success. This effective method pinpoints discrepancies between your existing documentation and stringent marketing authorization requirements.

Agency Interactions ›

Navigating the regulatory landscape is crucial to the successful development and commercialization of pharmaceuticals and biopharmaceuticals.

Drug development strategy and program  ›

Having a robust non-clinical drug development strategy and program is crucial for the efficient advancement of your drug candidates. With a comprehensive approach, you can ensure that all necessary studies are planned and conducted effectively, providing you the essential data required for successful clinical trials and regulatory approval.

Toxicology study Design ›

A proper non-clinical/toxicology study design is crucial in drug development as it ensures the safety and efficacy of your drug candidate. These studies help to identify potential toxicities and determine safe dosages, providing you with the essential data needed to ensure patient safety in clinical trials and to secure regulatory approval.
Rezual Karim
RA Manager

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Rezual Karim
RA Manager

Let's Connect

Talk to an expert