Core services

Strategic Scientific Consulting — Aligned with Your Goals

Expert guidance to align nonclinical development with clinical, regulatory, and CMC objectives, backed by risk assessment and scientific interpretation.

Nonclinical Program Development & Oversight — From Design to Delivery

Design, implementation, and monitoring of pharmacology, toxicology, and ADME studies, including CRO qualification and GLP oversight.

Regulatory Documentation & Compliance — Submission-Ready Quality

Authoring and QC of INDs, CTAs, NDAs, BLAs, MAAs, Investigator Brochures, summaries, and labeling with GLP/ICH compliance and SEND support.

Regulatory Interactions & Representation — Confident Representation

Strategic support and active participation in health authority interactions to ensure your nonclinical data is positioned clearly and defensibly.

Scientific & Operational Support — Precision in Execution

Independent program management, CRO oversight, literature review, data integration, and milestone tracking to ensure quality and efficiency.

Medical Device & Risk Assessment — Proven Expertise

Safety evaluation, impurity/leachable assessments, product quality review, and risk mitigation planning for devices and combination products.

Worldwide support through trusted, high-performing partners.

Nikao Life Sciences works with a vetted network of CROs and scientific partners across the US, Europe, India, and China, enabling sponsors to execute studies where the capabilities, timelines, and regulatory expectations best align with their program needs. Our partnerships allow us to coordinate study placement, support regional operational requirements, and maintain oversight throughout the lifecycle of your program — all while keeping scientific accountability centralized under Nikao.

What This Means for Clients:

Access to regional expertise without losing centralized project leadership
Strategic placement of toxicology, pharmacology, and ADME studies
Strategic placement of toxicology, pharmacology, and ADME studies
Consistent quality and data interpretation across global sites

Nikao ensures the right work happens in the right region without compromising quality, compliance, or efficiency.

Services