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Consultation participation and their own register declarations, side by side. Counts, not judgments — participation is not influence.

Counts here are a floor, never a total: they cover the 583 consultation files tracked so far (42,224 submissions, mostly 2025–26), so an organization's real filing history is larger, not smaller.

NOV
NovoBiome

Company · France

2
files engaged
of 583 tracked
2
positions filed
in those 583 files
declared FTE
self-declared
EP accreditations
as declared to the register

Files both filed on (2)

Medicinal products for human use · Standards of quality and safety for substances of human origin intended for human application

Register facts self-declared (snapshot 2 Sept 2026); cost bands are floors. Shared files are shared attention, not evidence of coordination.

What each said, in their own words

Their opening passages on the files they share, verbatim and in filing order. We do not summarize, compare, or characterize positions — read them at source.

Medicinal products for human use

MedTech Europe · filed 26 Apr 2021 · source

As the association representing the medical technology sector, MedTech Europe welcomes the recognition in the inception impact assessment that pharma health solutions bring about technological advances, and the inclusion of the potential of the digital transformation of health and care.

NovoBiome · filed 7 Nov 2023 · source

New category of biological medicinal products relevant for microbiome-based drugs NovoBiome supports the introduction of a new category of SoHO-derived medicinal products in the proposed Directive on the Union code relating to medicinal products for human use.

Standards of quality and safety for substances of human origin intended for human application

MedTech Europe · filed 14 Dec 2020 · source

MedTech Europe - the European trade association for the medical technology industry including diagnostics, medical devices and digital health - welcomes the opportunity to contribute to the initial consultation regarding the revision of the Union legislation on blood, tissues and cells.

NovoBiome · filed 8 Sept 2022 · source

Our company develops microbiota-derived Live Biotherapeutic Products We have a couple of concerns: 1. Regarding the updating of Pharmaceutical legislations, will SoHO or the legislation prevail? Shall we need to fulfill both drug and SoHO preparations requirements? 2. Regarding single strains, will they be considered as SoHO, which is highly questionable Best,

MedTech Europe · filed 8 Sept 2022 · source

MedTech Europe welcomes the Proposal for a Regulation on substances of human origin adopted by the European Commission in July 2022. We agree that the sector needs updated legislation, and the proposed text reinforces the rules for safety and quality. We are looking forward patients to having smooth access to products, the availability of which is uninterrupted on the European market.

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