Our Services
Comprehensive Bio-Science & Engineering Solutions
From toxicology strategy development to facility qualification, we provide end-to-end support tailored to your regulatory and development needs.
Toxicology Support
Custom toxicology plans for therapeutic programs through product registration aligned with regulatory expectations.
Our Approach:
- -Evaluation and qualification of CRO and vendors
- -Planning, designing and approval of study plans per regulatory requirements
- -On-site study monitoring of GLP and non-GLP study conduct at critical phases
- -Review of documents and reports
- -Coordinate with PM and CRO to maintain quality, timelines and budget
Key Capabilities
- Toxicology Strategy Development aligned with development goals
- Study monitoring from early stage single dose (MTD and PK) to chronic studies
- FEED, EFD and PPND study monitoring experience
- In-vitro Geno toxicity, Photo toxicity, Haemolysis studies
- Inhalation, Eco-toxicology, Physio-chemical studies
- Safety Pharmacology studies monitoring
Regulatory Support
Scientific team provides regulatory support for addressing and responding to queries from regulators.
Key Capabilities
- Interpretation of Regulatory correspondence and guidance
- Preparation of Pharmacology, Toxicology and Pharmacokinetic sections
- Regulatory submission documentation
- Preparation of Investigator Brochures
- CTD preparation and review
- Response to regulatory queries
Impurity Qualification
Thorough experience with mutagenic impurity assessments complying with ICH M7, Q3A/B standards.
Our Approach:
- -Supervise study conduct and review of study plan and report
- -ICH M7 compliance assessment
- -Q3A/B guideline alignment
Key Capabilities
- In-silico tools - rule based and statistical based programs
- (Q)SAR analysis for impurity assessment
- Quality report preparation for regulatory submission
- Safety assessment for APIs, excipients, extractable/leachable
- Device components safety evaluation
- Nitrosamine substances AI limits recommendation
Occupational & Environmental Risk Assessments
Comprehensive risk assessment evaluations for drug products, devices, and chemicals of interest.
Key Capabilities
- OEL (Occupational Exposure Limit) determination
- PDE (Permitted Daily Exposure) assessment
- Environmental Risk Assessments (ERA)
- Drug product risk evaluation
- Medical device risk assessment
- Chemical safety evaluation
Facility Design & Qualification
Extensive experience in Bio-safety laboratories and animal management with Concept-to-Qualification expertise.
Our Approach:
- -Bio-safety laboratory expertise
- -Animal management facility design
- -Mock audit preparation
- -Compliance documentation
Key Capabilities
- In-vivo and in-vitro testing facility design
- Concept to Qualification and Operation support
- Quality systems establishment
- Staff training programs
- Filing application support for certifications
- OECD GLP, AAALAC, NABL readiness
Cell Fractions for Metabolic Studies
Supply of high-quality cytosolic and microsomal fractions for specialized testing applications.
Key Capabilities
- Cytosolic fractions supply
- Microsomal fractions for metabolic studies
- Ames Test support materials
- Nitrosamine Risk Assessment study materials
- S9 fraction supplies
- Quality-assured biological materials
Ready to discuss your project?
Let our experts help you navigate regulatory requirements with confidence.