Regulatory Affairs Consultancy
We can provide your business with entry to new markets and a means to increase your current market share by effectively registering your products on a global basis (in Europe, USA, Canada, and Asia). We can assist in preparing the dossiers for notification worldwide, including risk assessments.
Detailed knowledge of the intrinsic properties of products
helps us to interpret environmental and toxicological test
results accurately and thus effectively represent customers with
regulatory authorities. Information is always treated
confidentially.
For example, one of our specialties is Food Contact and Drinking Water approvals. We are authorized to write Certificates of Guarantee for European manufacturers as well as obtain product approvals from the US FDA using either Food Contact Notification (FCN) or Food Additive Petition (FAP) submissions.
Accurate Material Safety Data Sheets are required by EU Directives, US OSHA HazCom Standard, and Canadian WHMIS regulations. We provide “one-stop shopping” from conducting toxicology data reviews to performing hazard determinations and translating this information into accurate Hazard Communication for global customers.
Our toxicologists are trained in government modeling software, which we use to predict product hazards and exposures. Key areas of expertise include classification, specifications and commodity codes, test methods, criteria, packaging and labeling, IBCs and tanks, transport provisions, and security issues.
We also provide customers with Transport Emergency (TREM) Cards, which companies in Europe and many other countries are required to have when transporting substances that may present a threat to human health or the environment.
Our experts are conversant with UN Regulations on the Transport of Dangerous Goods according to the requirements of the UN Committee of Experts (UN CETDG), ADR/RID (Road/Rail Transport in Europe), IMDG (Sea Transport), IATA and DOT, (International Air Transport and USA Road/Rail Transport).
Using our in-house knowledge and contacts with international regulatory bodies we ensure that your Safety Data Sheets are in compliance with the Globally Harmonized System for the classification and labeling of chemicals.
