AGROCHEMICAL AND FOOD ADDITIVES
AGROCHEMICALS
Compliance with REACH Regulation
We offer support for meeting REACH regulation from a technical and toxicological perspective by evaluating the available information and/or defining the toxicological studies required for this regulation.
Expert Opinions in Toxicology
Our technical staff can issue expert opinions in toxicology by conducting a case-by-case risk assessment. These opinions will be based on the outcome of previous studies and literature search on toxicological databases and regulatory disclosure documents.
[Read more] »
We can help our clients by offering toxicological and technical support for answering queries from regulatory agencies.
«[Read less]
Management and Monitoring of Nonclinical Studies
We offer management and monitoring activities for toxicological studies evaluating the safety of a chemical under the REACH regulations. The activities which we usually provide to our customers include involvement on study design, selection of suitable CROs around the world (considering expertise, slots and prices), requests for cost estimates to CROs, definition and critical review of protocol to ensure regulatory compliance, management tasks, direct communication with study directors, follow-up / monitoring of all study activities, coordination of tasks in multisite studies, assistance on any decisions along the study and critical review of the study report.
Toxicological Support during Registration Procedures
We offer technical and toxicological support during the elaboration of the pre-registration dossier for chemical industry regulatory departments.
FOOD ADDITIVES
Expert Opinions in Toxicology
Our technical staff can issue expert opinions in toxicology by conducting a case-by-case risk assessment. These opinions will be based on the outcome of previous studies and literature search on toxicological databases and regulatory disclosure documents. We prepare food ingredient qualification reports or help our customers to provide the adequate information to the agencies requiring clarifications as well as giving toxicological support for answering queries from regulatory agencies after submission.
[Read more] »
We also offer support for the verification of GRAS status by FDA or QPS status by EFSA.
«[Read less]
Management and Monitoring of Nonclinical Studies
We offer management and monitoring activities for toxicological studies evaluating the safety of ingredients under the Foods regulations. The activities which we usually provide to our customers include involvement on study design, selection of suitable CROs around the world (considering expertise, slots and prices), requests for cost estimates to CROs, definition and critical review of protocol to ensure regulatory compliance, management tasks, direct communication with study directors, follow-up / monitoring of all study activities, coordination of tasks in multisite studies, assistance on any decisions along the study and Critical review of the study report.
Toxicological Support during Registration Procedures
We offer technical and toxicological support during the preparation of the pre-registration dossier for Food industry regulatory departments.
[Read more] »
We calculate ADI (Acceptable Daily Intake) values according to EFSA, and evaluate the available information or design new studies for proposing ADI for a new food ingredient according to international guidelines.
«[Read less]
