Our Capabilities
Deep Expertise Across Sectors
We bring comprehensive experience across regulated industries with tailored solutions for each sector's unique regulatory requirements.
Sector Expertise
Industries We Serve
Small Molecules
Drug development support from pre-clinical to regulatory submission
Medical Devices & Combination Products
Comprehensive device regulatory compliance and toxicology support
Agro-Chemicals
Agricultural product safety assessment and global registration
Nutraceuticals
Dietary supplements and functional food regulatory compliance
Cosmetics
Safety assessment and documentation for cosmetic products
Global Regulatory Alignment
Our strategies align with international regulatory expectations, ensuring your products meet requirements across major health authorities worldwide.
FDA
FDA
United States
EMA
EMA
Europe
TGA
TGA
Australia
ANV
ANVISA
Brazil
Chi
China CSAR
China
CDS
CDSCO
India
Risk-Based Scientific Approach
- Toxicology strategies rooted in ICH and ISO standards
- Impurity qualification aligned with regulatory expectations
- Sound scientific rationale tailored to development pathway
- Evidence-based risk assessment methodologies
End-to-End Preclinical Support
- Facility Development and Qualification
- Training programs and Mock audits
- Study design review and optimization
- Report preparation and regulatory submission
- From early-phase hazard assessment to submission
Conscious of Global Standards
ICHISOOECDAAALACGLP