What is it?
Testing under regulatory frameworks is the structured, science-based process of generating and evaluating data to demonstrate that substances, mixtures, and products meet legal safety and compliance requirements before they are placed on the market or used.
Regulatory frameworks specify standardised endpoints that must be addressed. These may include:
- Physico-chemical properties
- Human health toxicity
- Ecotoxicology and Environmental fate and behaviour
- Exposure and use-related characteristics
Testing is conducted according to internationally recognised guidelines, such as:
- OECD Test Guidelines
- EU and ISO standards
- Good Laboratory Practice (GLP) principles
This harmonisation ensures data quality, reproducibility, and acceptance by regulatory authorities worldwide.
What you get
Client-focused delivery
Expert consultants
Scientifically robust
Regulatory compliant
Efficient and cost-effective
Aligned with current guidance and expectations
What we offer
We handle administrative and scientific tasks, such as:
Study Preparation & Contract Management
We prepare comprehensive test item information sheets, arrange and send samples to the laboratory, and manage the contract signing process. This ensures that all required documentation and materials are in place before testing begins, allowing the study to start smoothly and in compliance with regulatory expectations.
Study Plan Review & Regulatory Alignment
We review study plans against relevant guidelines to ensure they are fit for purpose and meet regulatory requirements. Where necessary, we communicate directly with laboratories and regulatory authorities to clarify expectations and confirm that the proposed study design is appropriate and compliant.
Study Monitoring & Scientific Support
We monitor the study throughout the full duration of testing. This includes responding to laboratory questions regarding the substance, supporting the development of appropriate analytical methods when required, and discussing and agreeing on any necessary amendments during the course of the study to ensure continued compliance and scientific integrity.
Reporting, Interpretation & Sponsor Communication
Sponsor Updates & Regulatory Impact Assessment
We keep the Sponsor informed throughout the study, providing updates, interpreting results, and clearly explaining their impact on the overall registration strategy. This ensures the Sponsor understands both the scientific outcomes and regulatory implications.
Study Report Review & Quality Assurance
We review draft and final study reports, including those for method validation, preliminary studies, and main studies. This ensures accuracy, regulatory compliance, and high-quality documentation before submission or further use.
Our Process
Step 1: Test Item Preparation & Documentation
We prepare detailed test item information sheets, coordinate and send samples to the laboratory, and manage contract agreements to ensure all materials and documentation are ready before testing begins.
Step 2: Study Plan Review & Compliance Check
We review study plans against applicable guidelines to confirm they are fit for purpose and communicate with laboratories and regulatory authorities as needed to ensure the study design is scientifically sound and compliant.
Step 3: Study Monitoring & Laboratory Support
We monitor the study throughout testing, respond to laboratory questions, assist in developing appropriate analytical methods when required, and discuss any amendments to maintain compliance and scientific integrity.
Step 4: Data Interpretation & Risk Assessment
We interpret test results within a risk assessment framework, evaluating their implications for regulatory compliance and keeping the Sponsor informed of progress and findings.
Step 5: Reporting & Quality Assurance
We review draft and final study reports, including method validation, preliminary studies, and main studies, to ensure accuracy, clarity, and readiness for regulatory submission.