Successful marketing of products requires careful planning. We start by understanding your needs and expectations, clarify the legal status of your product, propose the regulatory pathway(s) to approval and assess the feasibility of the project.

Scientific data on the composition, safety and efficacy of your product are key elements for a successful project. We analyse the available information, identify the data gaps and propose options how to address them.

It is important that studies on the chemical characterisation, safety and efficacy are performed in line with current guidelines and standards.

We support you during the planning and organisation of studies, act as study monitor, and help you with the interpretation of results.

For EU applications, we also engage on your behalf with EFSA through the portal ‘Connect EFSA’ to:

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Notify studies in EFSA’s database

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Request pre-application ID

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Submit the list of intended studies for renewal applications

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Obtain renewal pre-submission advice

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Request general pre-submission advice

Once all necessary data has been gathered, the information is compiled in a dossier and submitted with the application to the regulatory authorities.

We prepare the dossier in line with the regulatory requirements, perform systematic/extensive literature reviews and support applicants during the submission (including communication with the authorities).

For EU applications, we offer to build-up dossiers in the E-Submission Food Chain Platform, identify confidential information and support clients in the drafting of confidentiality requests.

During risk assessment, risk assessors may request additional information from the applicant to establish the safety of your product. This data must be submitted in timely manner. If unaddressed, data gaps may result in an unfavourable opinion and jeopardize the market approval of the product.

In this situation, we offer critical review of the request for information or the evaluation report and present options how to follow-up. If needed, we seek clarification from the authorities.

Our services include the assessment of scientific opinions, comparison & review of the corresponding draft acts and correspondence with the authorities in case of any issues.