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Global Chemical Registration

CEHTRA help with global registration of chemicals CEHTRA can help you register new chemical substances simultaneously under the various chemical registration schemes throughout the world

Aligning the global registration of a new chemical product with proposed launch dates requires careful planning and execution

Multiple registration dossiers need to be prepared according to the specific local regulatory requirements in place in key marketplaces throughout the world, and no two chemical registration schemes are the same. Expertise is required to understand the similarities and differences between the various schemes; in particular the prescribed test data requirements, the flexibility to use alternatives to testing, and the evaluation timeframes.

A well planned and executed testing and notification strategy that minimizes the need to conduct new laboratory testing, and factors in the time required to gain approval, can save you money and help ensure that your products can be introduced on time.

CEHTRA’s solutions to register your new chemical products globally

  • Interpreting the registration schemes in jurisdictions of interest as they relate to your new chemical substances and products;
  • Completing comprehensive preliminary strategic reviews to determine the need for registration, and the type of registration required;
  • Developing and implementing notification strategies that are designed to coordinate the gaining of regulatory approval with product launch dates;
  • Designing testing programs that ensure, where possible, that all necessary laboratory testing will be conducted following test protocols that will be accepted globally;
  • Monitoring laboratory testing to ensure all hazard and exposure data gaps are fulfilled with fully valid and scientifically rigorous studies; CEHTRA has links with some of the best laboratories in the world;
  • Preparing detailed scientific arguments to justify the use of study waiving, surrogate data, and/or SAR/QSAR, in lieu of generating new laboratory test data;
  • Preparing and submitting registration dossiers that are of sufficient detail to satisfy the demands of regulatory authorities;
  • Communicating with the authorities on your behalf to discuss matters relating to the notification and/or assessment of your new chemical substances.

CEHTRA’s Experience, Proof of our commitment

CEHTRA experts have successfully registered hundreds of new chemical substances throughout the world, including registrations in Europe, Canada, United States, Australia, China, Japan, and Korea. When you hire CEHTRA you gain access to decades of scientific and regulatory experience with chemical assessment schemes, and to experts that best suit your needs in terms of geographic proximity, time zone, language, and cultural habit.

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®Cehtra • March 2018