Rovi Pharma Industrial Services
ROIS CDMO
Nous sommes reconnus pour notre expertise, notre dévouement constant et notre transparence dans le domaine de la fabrication en sous-traitance. Bienvenue chez ROVI.
- Type
- brand seeking distribution
- Location
- Madrid, Spain
- Website
- https://www.roviservices.com
- Categories
- Production pharmaceutique, Emballage et fournitures d'impression, Fournitures médicales et de santé
Listed in a source registry
Verified facts
- domain-registered (green), checked 2026-08-09 Domain registry record
- sanctions-clear (green), checked 2026-08-09 OpenSanctions
- corporate-mail-on-domain (green), checked 2026-08-09 Mail server of the company domain
- registered-manufacturer (green), checked 2026-08-21 Superintendencia de Regulacion Sanitaria de El Salvador, listado de productos farmaceuticos con registro sanitario vigente
- lei-active (green), checked 2026-08-23 GLEIF global LEI register (golden copy)
- public-contract-awarded (green), checked 2026-05-13 TED (Tenders Electronic Daily), EU public procurement award notices Ici l'attribution porte aussi un contrôle fait par d'autres: dans l'UE et l'EEE, l'acheteur public doit exclure les candidats condamnés pour fraude, corruption ou blanchiment, ainsi que ceux dont une décision définitive a établi des dettes fiscales ou sociales. Directive 2014/24/EU, Article 57 (exclusion grounds)
- facility-registered (green), checked 2026-08-30 European Industrial Emissions Portal (E-PRTR / IED), European Environment Agency
- operating-permit (green), checked 2026-08-19 EudraGMDP manufacturing authorisation register (EMA)
- debarment-clear (green), checked 2026-08-09 OpenSanctions
- public-subsidy-received (green), checked 2026-08-16 BDNS, Base de Datos Nacional de Subvenciones (Ministerio de Hacienda)
- vat-valid (green), checked 2026-08-16 VIES (European Commission)
Import rules for these goods
- Medical devices sold in the EU must carry CE marking under the Medical Device Regulation (EU) 2017/745, with a conformity assessment matched to the device risk class. European Commission (MDR)
- For the US market, the maker must have an FDA device establishment registration and product listing; most instruments also need 510(k) premarket clearance. US FDA (devices)
- If the goods are paper, board or printed products, EU imports fall under the Deforestation Regulation (EUDR) due-diligence regime; packaging machinery itself does not. European Commission (EUDR)
- Medicines imported into the EU must come from a site holding an EU GMP certificate, and the importer needs a manufacturing/import authorisation. European Medicines Agency (GMP)
- No public registry exists for certificates of this kind in this sector: conformity is declared by the manufacturer. European Commission: CE marking, manufacturer's conformity assessment