Product Safety & Regulatory Support

Dossier Preparation

ENVIRON has been providing risk assessment support to the chemicals industry for 25 years, and we have extensive experience preparing pre-market notification and dossier submission packages, including the necessary summaries, evaluations and risk assessments, as well as all the paperwork and conversion to a digital format when necessary.

We have significant experience in alternative testing methods and can, where scientifically justifiable, prepare expert statements for waiving particular tests, as well as delivering the actual data requirement results based on these approaches. Because we do not carry out testing in-house, we are able to provide objective and independent advice about the most cost-effective and appropriate methods available.

We can assist clients by:

• preparing and filing registration dossiers.
• validating registration dossiers prior to submission to the ECA.
• arguing data waivers and evaluations, and justifying intelligent testing methods.
• gathering information from the supply chain on substance use.
• develop Exposure Scenarios and evaluate exposure across the product life cycle.
• preparing all or part of Chemical Safety Reports.
• preparing Safety Data Sheets.
• providing Classification and Labeling advice.
• compiling physicochemical/human-health assessment/environmental risk assessment data packages.