Registration and Submission

The registration of chemicals is standard practice in almost all countries around the world. Although specific registration processes vary, clear, accurate submissions supported by robust scientific and technical data are essential.

Submitting comprehensive, compliant dossiers ensures a smooth regulatory journey for your chemical and speeds up time to approval.

Understanding and managing chemical registration and submission 

In a global marketplace, it can be hard to keep track of compliance requirements for chemical registrations for each regulator. You need to compile dossiers correctly, use appropriate data and adhere to specified timelines and requirements. 

It is also important to understand whether your chemical requires full registration or whether notification is appropriate. This means knowing how to interpret regulatory requirements based on your chemical’s properties and use. Once a dossier is submitted, registrants must respond to a regulator’s questions in a timely way and defend your registration and dossier. 

Global chemical registration and submission 

Our global reach is facilitated through a network of experts located in key markets across the Americas, Europe and Asia. With staff coming from industry, regulatory agencies, consultancies and research institutes, there is a wealth of expertise to call on. We’ll guide your chemical through registration and submission, defining a pathway that is efficient and cost-effective. This may mean:

• dossier compilation and submission
• use of read-across approaches
• use of alternative approaches, e.g., QSARs
• expert statements and waivers
• facilitation and provision of letters of access (LoA) to available data
• designing and conducting safety studies
  

All registration and submission activities are performed to ensure compliance to regulatory processes and procedures. This means building compelling scientific arguments based on robust and accurate data in a way that is readily acceptable to authorities.

Support beyond registration and submission

Regulators may challenge your submission, and that’s when our advocacy expertise is invaluable. We can support you by defending submissions to regulators in the form of written, telephone and face-to-face communications, as required.

Even after registration and submission, ongoing compliance and support of a submission is important. This ensures your dossier stays aligned to the current regulatory standards, keeping your chemical on the market.