Toxicological Assessments for Safety Compliance (PDE, OEL & SDS)
Safety is not just a regulatory requirement: it is key to robust and sustainable operations.
Are you developing a new biological or biotechnological API and need expert support in toxicological assessment and safety documentation?
With this set of reports, you will receive specialized support in:
- Determining PDE (Permitted Daily Exposure) values for cleaning strategies and cross-contamination control
- Calculating OEL (Occupational Exposure Level) values for worker protection
- Creating Safety Data Sheets (SDS) tailored to complex substances
We work to translate complex data into practical decisions, aligned with regulatory requirements and industry best practices.
Based on preclinical and clinical data provided by you, we develop robust and defensible scientific reports that enable:
- Assessing occupational health and safety risks
- Defining science-based exposure limits
- Facilitating the identification of the active substance
- Establishing safe handling and transport conditions
- Name and address of the company
- Name of the API
- Dosage form
- Route of application of the API or of the potential next product that is produced in the same facility (cleaning validation)
- Preclinical and clinical data
Issuing of the PDE report
- According to EMA guideline in English
- Issued on your company name
- Issued by European toxicological experts (ERT)
Issuing of the OEL report
- Extensive bibliographic research
- OEL determination according to internationally accepted guidelines
- Categorisation with regard to the specific working conditions according to national requirements or SafeBridge® banding scheme
Issuing of the safety data sheet (SDS)
- GHS/CLP hazard classification and REACH-compliant SDS authoring
Do you have any Questions?
Talk to our customer advisors
Do you have any questions about our products? We are here to help.
