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Expertise & Global Reach

Home > Expertise & Global Reach

Areas of Expertise

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
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

  • United States (US)
  • European Union
  • China
  • India

Centralized Global Oversight

  • Single governance framework
  • GLP-aligned monitoring
  • Unified reporting & data integrity

Why Global Presence Matters

  • Faster multi-region execution
  • Consistent regulatory quality
  • Reduced operational risk
Work With Us Globally