Strategic. Scientific. Global.

Science That Moves Innovation Forward

Nikao Life sciences is a scientific consulting firm specializing in nonclinical program development, toxicology, pharmacology, ADME, risk assessment, and regulatory strategy. We design and oversee programs that meet global expectations and are ready for agency review. With established CRO and technical partners across the US, EU, China, and India, we deliver science-driven, execution-ready solutions.

Commitment to Quality & Scientific Rigor

Responsive, Expert Guidance When You Need It

Consistency, Integrity & Compliance

What We Do

Nikao Life Sciences provides comprehensive scientific and regulatory consulting to support biotech, pharma, and medical device innovators. Our expertise spans nonclinical strategy, study oversight, regulatory documentation, agency engagement, scientific operations, and product quality evaluation. We align science, operations, and regulatory expectations to ensure your program is built on rigorous evidence and ready for global review.

Strategic Scientific Consulting

Nonclinical Program Development & Oversight

Regulatory Documentation & Submission Support

Regulatory Interactions & Representation

Scientific & Operational Support

Medical Device & Risk Assessment

Nikao Life Sciences brings deep scientific and regulatory expertise across multiple therapeutic modalities, nonclinical disciplines, and global regulatory frameworks. Our team provides comprehensive support from study design to submission, backed by specialized knowledge across key development areas.

Expertise Highlights:

Therapeutic Modalities

Small molecules, biologics, cell and gene therapy, vaccines, combination products

Nonclinical Study

General toxicology, DART, juvenile toxicity, Safety Pharmacology (CV, CNS, Respiratory), ADME / PK

Administration Routes

Oral, IV, SC, dermal, ocular, inhalation, intranasal, intratumoral, and direct CNS administration

Regulatory Expertise

FDA, EMA, MHRA, PMDA, Health Canada, ICH S-series(S1–S12), GLP compliance, SEND requirements

PRODUCT QUALITY & RISK ASSESSMENT

Our expertise spans impurity qualification, extractables and leachables evaluations, excipient justification, and advanced in silico toxicology modeling.

GLOBAL EXECUTION CAPABILITY

Nikao Lifesciences maintains a strong international network of CROs, laboratories, and scientific partners across the United States, Europe, China, and India

GLOBAL CAPABILITY

Global Partnerships / Global Execution Capability

We partner with leading CROs across major regulatory regions, enabling seamless execution, oversight, and compliance across borders.

Global CRO Network

Centralized Global Oversight

Why Global Presence Matters

TESTIMONIAL

Customer Feedback

“Nikao Lifesciences provided critical regulatory guidance that streamlined our IND package.

Darlene Robertson

Director, Biotech Startup

Their oversight of our toxicology studies and CROs gave us confidence before meeting regulators. They operate like an internal team

Courtney Henry

VP, Preclinical Strategy, Pharma

Their expertise in toxicology and study oversight saved us both time and cost, ensuring our project stayed on track

Kathryn Murphy

VP, Pharmaceutical Development

A partner that understands both science and strategy, bringing clarity and confidence to every stage of the project

Jack Smith

CEO, Medical Device Company

They don’t just generate documents—they build robust, defensible programs that stand up to global scientific and regulatory review.

Rasalina William

Director of Toxicology, Biotech Startup

Thought Leadership

Latest Insights

Regulatory expectations evolve. So should your strategy. Read our latest guidance on nonclinical development, toxicology, and global execution.

Five Red Flags in Vendor Study

Five Red Flags in Vendor Study Reports Before Submission What Sponsors

December 21, 2025
1,526 views

Designing IND-Enabling Toxicology Studies the Right

Designing IND-Enabling Toxicology Studies the Right Way Avoiding Common Pitfalls and

November 13, 2025
1,526 views

How to Qualify a CRO in

How to Qualify a CRO in China or India Global Sites,

November 13, 2025
1,526 views

SEND Isn’t Just Formatting

SEND Isn’t a Formatting Exercise It’s a Submission Risk Understanding Why

November 13, 2025
1,526 views