Newsletter June 2020
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Redebel Regulatory Affairs RRA) has extensive experience in preparing the authorisation applications and in regulatory compliance of biocidals products in the European market. This experience confirms that the market structure for biocidals products (mainly made up of SME) and the profit margins generated by these products make regulatory-linked cost management a huge challenge for this sector.
Various strategies are possible nowadays to face up to these regulatory obligations set out by Regulation (EU) 528/2012 (BPR). One of these strategies is to pool the application creation costs, by bringing players in the same sector together in a Consortium to prepare a joint submission. RRA has been operating as a consultancy firm for several years in managing and monitoring the technical aspects of this type of cooperative initiative and in preparing joint submissions. RRA has now decided to go further by creating an exchange platform where manufacturers can state their interest in a particular substance and the type of product in which it is used.
If this type of initiative is of interest, please register yourself below !
Do not hesitate either to contact us directly on this address firstname.lastname@example.org for any question or expression of interest in an active substance/product type combination that has yet to be published.
Registration on this site indicates your interest in cooperating with other stakeholders in the same sector. Under no circumstances does this expression of interest make it mandatory to join any Consortium that may be formed. RRA takes charge of assembling the interests of different players in the marketplace using the following procedures:
The use of the registration system is free (Registration Phase). The resulting actions will be subject to a financial shareholding for the interested companies based on an agreement entered into with RRA and the firm of specialist lawyers if necessary (Compliance Phase and Submission Preparation Phase)
All information exchanged in this context is confidential. RRA will be responsible for contacting individually every company that has expressed interest (Registration Phase) in order to establish and non-disclosure agreement before any exchange of information.