STRATEGIZE. EXECUTE. ACHIEVE
Experience That Navigates Success
Integrated Engineering & Bio Solutions for Regulated Industries. Driving innovation, safety, and compliance through specialized services.
25+ Years
Leadership experience in Pre-Clinical R&D and CRO sector
Global Expertise
Multi-sector expertise across Drug, Device & Agro-Chemical
Scientific Depth
Integrated approach from Early Hazard Assessment to Submission
Global Standards
Conscious of ICH, ISO, OECD, AAALAC, GLP requirements
What We Offer
Our Services
Comprehensive Bio-Science and Engineering solutions tailored to your regulatory and development needs.
Toxicology Support
Strategy development from early single-dose studies to chronic & carcinogenicity studies. GLP & non-GLP study monitoring.
Learn more→Regulatory Support
Interpretation of regulatory correspondence, preparation of CTD, Investigator Brochures, and pharmacology documentation.
Learn more→Impurity Qualification
ICH M7, Q3A/B compliance, (Q)SAR analysis, Nitrosamine risk assessment, and safety evaluation for APIs and excipients.
Learn more→Risk Assessments
OEL, PDE determination, Environmental Risk Assessments (ERA) for drug products, devices, and chemicals.
Learn more→Facility Design & Qualification
Concept-to-qualification support for in-vivo and in-vitro testing facilities. GLP, AAALAC, NABL readiness.
Learn more→Cell Fractions Supply
Cytosolic and microsomal fractions for Ames Test and Nitrosamine Risk Assessment studies.
Learn more→Sector Expertise
Industries We Serve
Deep experience across regulated industries with tailored solutions for each sector.
Pharmaceuticals
Small molecules, biologics, and drug development support
Medical Devices
Combination products and device regulatory compliance
Agro-Chemicals
Agricultural product safety and regulatory submissions
Nutraceuticals
Dietary supplements and functional food compliance
Cosmetics
Safety assessment and regulatory documentation
Global Compliance
Regulatory Alignment
Our strategies align with international regulatory expectations across all major health authorities worldwide.
Risk-Based Scientific Approach
We develop toxicology and impurity qualification strategies rooted in ICH and ISO standards, with sound scientific rationale tailored to your development pathway.
End-to-End Preclinical Support
From early-phase hazard assessments to regulatory submissions, we provide seamless, full-spectrum support including facility development, qualification, training, and mock audits.
Partner with BETS for Scientific & Regulatory Excellence
Let us support your development program with our proven expertise in Engineering and Bio-Science consulting.