Frequently asked questions
Established in 2003, PERSEUS bvba is a partnership of biosafety and regulatory experts from diverse fields of application.
In which regions do you operate?
Perseus is registered in Belgium, embedded in one of Europe’s most active Life Science regions and closely located to the Europe Commission’s administrative centres. Via our network of associates, Perseus operates mainly throughout Europe and Russia, yet some of our international projects include activities in Asia, Africa, Central and Latin America. Furthermore, Perseus collaborates with other service providers located throughout the globe and operating according to similar philosophy and customer orientation..
Who are your customers?
Our customers include members of both private and public sectors. In the private sector we work for small, medium and large size companies from bioscience, food industries and trade organizations. National governments and the European Commission are examples of our public sector customers.
What about confidentiality?
We know that our clients require information to be treated in confidence. Therefore we start from the basis that any received information that is not yet in the public domain should be handled confidentially. We are willing to commit to any reasonable confidentiality agreement.
Do you draft regulatory applications?
Yes, we do compile regulatory applications. First, in a regulatory assessment, legislations applicable to your case and related data requirements are defined. If information gaps exist, recommendations for generation of additional information are made. Once all necessary data are available, we can prepare your dossier for submission to the relevant regulatory agencies.
Do you run toxicological testing programs?
The toxicological assessment of a novel type of food/feed is an important part of your application file. We will advise you on the toxicological data that should be included in your dossier, but Perseus does not design nor carry out the toxicology testing programs. We refer for this to facilities specialized in conducting toxicological studies according to internationally agreed protocols.
Do you interact with regulatory authorities?
Yes, we do interact with regulatory authorities on applications. Interaction can occur at different stages during the preparation of your application file, at the beginning of the procedure or during the review of your dossier by the relevant authorities. In Europe, interaction is also done at different levels, i.e. Member States Competent Authorities or the European bodies (EFSA or Commission).