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Consortium and SIEF Management and Representation

The preparation of a registration dossier often requires communication and co-operation with other registrants. In particular, registrants are often required to come together to discuss data sharing, preparation of technical dossiers and suitability of data. As such, this process requires technical and regulatory knowledge. ReFaC offers various services to support companies at every stage of the registration process. In particular, ReFaC can represent our clients at SIEF or consortium meetings and provided detailed feedback and technical analysis of the discussions.

ReFaC can also assist with the formation and management of consortia and are well placed to deal with tasks such as data collection and validation, cost-sharing arrangements, organisation of technical work and day-to-day administrative tasks required to run the consortium (i.e. management of the budget etc).

In addition, if you are a company looking to join a consortium, ReFaC can advise you on any regulatory issues and also represent your company within the consortium. For example, in technical discussions relating to data-sharing or substance sameness.

Contact ReFaC now if you are interested in our consortium services. We will be happy to provide you will a detailed quotation according to your needs.

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