K-REACH registration: why use a service provider?

July 14, 2020
Published 

An expert knows which tests to perform

Each K-REACH Registration dossier requires a certain number of tests to be carried out in order to better identify a given substance. The two main families of tests are:

  • Analytical tests ; they enable the substance to be characterised from a physico-chemical point of view (NMR, UV, DRX etc.).
  • Toxicological and eco-toxicological tests, in the case of a submission as the lead registrant. These tests assess the impact of the substance on human health and the environment.

However, depending on the nature of the substance, not all tests are relevant and it may sometimes be necessary to choose a protocol that is more suitable than another for a specific substance. This requires a solid knowledge of both chemistry and toxicology; which a consulting firm can provide. Outsourcing the choice of tests therefore allows you to rely on the informed choice of a professional.

They have a network of trusted laboratories

In order to be able to meet regulatory deadlines, it is absolutely essential to work with a network of expert and qualified laboratories in cases where testing is required.

Indeed, the availability of laboratories is a crucial issue since it implies the respect or not of the regulatory registration deadlines. Working with several partner laboratories makes it possible to better distribute the tests to be carried out and to anticipate possible overloads. Moreover, working regularly with partner laboratories allows you to benefit from preferential deadlines and competitive costs.

They will be able to defend your interests and take care of the management of the CICO on your behalf

The service provider acts in respect of the confidentiality of your data as an intermediary between your company and the other member companies of the CICO (the Korean equivalent of the SIEF, Substance Information Exchange Forum). They can:

  • Carry out the purchase of Letters of Access (LoA) and validate the data sharing conditions and associated test costs on your behalf.
  • Manage CICO newcomers, negotiate CICO contract terms and LoA invoicing for CICO members if you choose to register as a Lead Registrant

They can also help you with conflict management. Experience has shown that some Lead Registrants can be difficult to contact by Member Registrants who want to join a CICO. The provider can therefore "absorb" for you the management problems that may arise during the process of collecting information and drafting administrative documents.

This external intermediary role of the provider is not only beneficial to conflict management, but also relieves you of unavoidable and potentially very time-consuming administrative procedures.

They are familiar with the platforms used for K-REACH Registration

The management of the CICO and the submission of the dossier are carried out via the K-REACH Portal IT platform.

The use of this computer tool requires specific training. There are of course tutorials, trainings, webinars to train you on this subject but nothing can replace the efficiency acquired by a long experience in the use of this tool.

A service provider allows you to save time compiling data, online submission, administration of the K-REACH Portal account but also training time to these computer tools.

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