Non-clinical Consulting Services

Our Services

Our comprehensive service portfolio ensures that we meet your project's unique needs. Below are the primary services we offer:

• Phase-Specific Strategy Guidance & Gap Assessment: We provide comprehensive phase-specific strategy guidance to help you understand the regulatory landscape and identify any gaps in your development plan. In this respect, our team of experts assesses your current data, regulatory requirements, and future studies to create a roadmap that aligns with your goals and timelines.
• Preclinical Study Design and Strategy: Our team of experts collaborates with clients to design and implement comprehensive preclinical study plans, ensuring that studies are scientifically sound and aligned with regulatory expectations. Services include toxicology study design, pharmacokinetics and ADME (absorption, distribution, metabolism, and excretion) studies, efficacy studies in relevant animal models, and safety pharmacology assessments.
• Performance of Non-clinical Study Audits: Our team performs thorough non-clinical study audits, identifying any deviations and recommending corrective actions to ensure compliance with Good Laboratory Practices (GLP).
• Protocol and Report Review for PK/PD/Toxicology: Compliance and accuracy are pivotal in report generation and protocol adherence. We will review your protocols and reports for pharmacokinetics, pharmacodynamics, and toxicology to ensure they meet the regulatory guidelines and are scientifically sound.
• Study Report Composition, Review & Results Interpretation: Our services extend to the composition, review, and interpretation of study reports. We ensure your data is presented clearly, accurately, and compellingly to regulators and stakeholders, enhancing the credibility of your submission.
• Designing, Preparing, and Submitting Non-clinical Sections of Regulatory Documents: Our expertise extends to regulatory submissions, assisting with the design, preparation, and submission of non-clinical sections for critical documents such as investigator's brochures (IBs), investigational new drug (IND) applications, new drug applications (NDAs), biologic license applications (BLAs), and marketing authorization applications (MAAs).