--- title: Supplier verification for medtech and pharma | Aurienta description: Independent dossiers of checked facts on a supplier, including certificates and ESG evidence, so European buyers can approve samples with confidence. image: https://www.aurientalife.com/hubfs/aurienta-og-gsv.jpg --- [![Aurienta Life Sciences](https://www.aurientalife.com/hubfs/e7fb8f607b6f86721686b9aee2d17999.png)](https://www.aurientalife.com/?hsLang=en) [Supplier Verification](https://www.aurientalife.com/gsv)[Market Entry](https://www.aurientalife.com/market-entry?hsLang=en)[Distribution](https://www.aurientalife.com/distribution?hsLang=en)[About](https://www.aurientalife.com/about?hsLang=en)[Meet us at CPHI Milan](https://www.aurientalife.com/cphi-milan?hsLang=en) Global Supplier Verification · GSV # Know your supplier before the first sample One independent dossier with checked facts about a supplier, so European buyers can say yes to samples with confidence. The GSV Buyer Readiness Dossier puts everything in one place, checked against official registers and issuers. [Discuss a dossier](https://www.aurientalife.com/cphi-milan?hsLang=en)[See a sample dossier](https://www.aurientalife.com/gsv#sample) The timing problem ## Due diligence usually comes too late Most buyers ask for supplier information after samples are tested and development has started. Changing supplier at that point is expensive. For a device maker, a new critical material after design freeze can mean new biocompatibility testing and a notified body change notification. For a pharma company, a new API or excipient source needs new stability data and a regulatory variation. Buyers also need ESG data from new suppliers for their own reporting, and a missing rating found late can stop a project. GSV moves the questions to the start. No quality manager wants to explain a supplier problem after development money is spent. 01 Scouting Find candidate suppliers 02 Due diligence The dossier is delivered here GSV dossier 03 Samples From a known, documented site 04 Development Investment based on known facts 05 Qualification Your audit focuses on open items 06 Regulatory filing Documentation gaps known upfront For whom ## Two ways to commission a dossier We believe trust between buyers and suppliers should be built on facts anyone can check. ### For suppliers in China and Korea Answer EU buyers' questions before they are asked, in English and in a format quality teams recognise. Send the dossier during scouting or tenders. ### For EU buyers and start-ups Compare candidate suppliers before ordering samples, without a procurement or supplier-quality team of your own. Every dossier states on page 1 who commissioned it and any commercial relationship Aurienta has with the supplier. For suppliers ## Give European buyers the evidence they need to say yes “Our product meets the specification. So why don’t European buyers reply?” European buyers rarely reject the product itself. They hesitate because they cannot check the facts about a new supplier from a distance. As an independent European company in Amsterdam, we check your company, certificates and sites at the source. European buyers get evidence they can verify themselves, before they order a sample. Let the evidence speak for your company, so the product can speak for itself. ### A new supplier needs evidence A European quality team must explain every new supplier choice to its notified body or inspector. Without evidence, the safest choice for them is to wait. ### Qualification takes months Every buyer sends its own questionnaire and document requests. Each round takes weeks, and buyers often choose another supplier in the meantime. ### A certificate copy is not enough European buyers now check every certificate with the issuer themselves: the site, the scope and the validity. They want evidence they can confirm. ### ESG evidence is now part of the decision European buyers must report on their supply chain. A supplier without an EcoVadis rating or ISO 14001 often drops out before the product is even tested. We can help you prepare. Without a dossier - Unanswered emails to European buyers - The same questionnaire answered again and again - Samples sent before the buyer knows your company - Gaps found in the buyer’s audit With a GSV dossier - **Evidence buyers can check** - **One dossier for every buyer you approach** - **Samples ordered on known facts** - **Gaps closed before a buyer’s audit** You invest once, and every European buyer you approach can use the same dossier. Looking for introductions to European buyers as well? Our [Distribution](https://www.aurientalife.com/distribution?hsLang=en) and [Market Entry](https://www.aurientalife.com/market-entry?hsLang=en) teams can help. Any commercial relationship with you is stated on page 1 of your dossier. What's inside ## What a dossier covers Separate element sets for medical devices and pharmaceuticals. Built on the industry-standard supplier questionnaire that pharma buyers already use, plus an Aurienta layer for verification, know-your-customer (KYC) checks, environmental, social and governance (ESG) evidence and medtech-specific requirements. ### Identity and ownership Legal entity, registrations, group structure and all sites, checked in official company registers, such as China’s National Enterprise Credit Information Publicity System. ### Public records Public enforcement actions, recalls, court cases and news coverage, searched in English and the local language. ### Regulatory status and certificates Licences, registrations and certificates checked with the issuing body or the official database, such as NMPA, NANDO and EudraGMDP. ### EU compliance screening The checks EU rules require from every buyer: beneficial owners, sanctions, politically exposed persons (PEP), export control, anti-bribery and the EU Forced Labour Regulation. ### Materials, process and supply chain Raw-material sources, change notification, sub-suppliers, capacity and continuity. ### Document readiness Every document a buyer will ask for, whether it exists, whether it is EU-usable and when it expires. ### ESG and responsible sourcing EcoVadis rating and medal, ISO 14001 and ISO 45001 certificates, social audits such as SMETA or amfori BSCI, the PSCI self-assessment for pharma suppliers, a signed supplier code of conduct, carbon footprint data and, for devices, conflict minerals declarations. Each checked with the platform or issuer where possible. Evidence labels ## Every fact carries a label Each section is also marked Complete, Partial or Missing. That measures whether the information is complete and checkable. It does not measure whether the supplier complies. Verified Confirmed by Aurienta with an official register or the issuing body, or observed directly on site. Declared Stated or provided by the supplier, but not confirmed with the issuer. Open Not available, not accessible or inconsistent. **Example:** an EcoVadis Silver medal confirmed on the EcoVadis platform is Verified. A sustainability policy sent by the supplier is Declared. Sample ## What a dossier looks like Three pages from a sample dossier for a fictional supplier. Every dossier follows the same structure, with separate element sets for medical devices and pharmaceuticals. [![Sample dossier page 1: supplier details, who commissioned the dossier, and the status of each section](https://www.aurientalife.com/hs-fs/hubfs/gsv-sample-dossier-summary.jpg?width=894&height=1263&name=gsv-sample-dossier-summary.jpg)](https://www.aurientalife.com/hubfs/gsv-sample-dossier-summary.jpg?hsLang=en) Page 1: who commissioned it, and the status of every section [![Sample dossier page on regulatory status and certificates, with each fact labelled Verified, Declared or Open and its source](https://www.aurientalife.com/hs-fs/hubfs/gsv-sample-dossier-certificates.jpg?width=894&height=1263&name=gsv-sample-dossier-certificates.jpg)](https://www.aurientalife.com/hubfs/gsv-sample-dossier-certificates.jpg?hsLang=en) Every fact labelled, with its source and open items for the buyer [![Sample dossier page on document readiness: which documents exist, which are usable in the EU and when they expire](https://www.aurientalife.com/hs-fs/hubfs/gsv-sample-dossier-documents.jpg?width=894&height=1263&name=gsv-sample-dossier-documents.jpg)](https://www.aurientalife.com/hubfs/gsv-sample-dossier-documents.jpg?hsLang=en) Document readiness: what exists, what is EU-usable, what expires How it works ## From enquiry to dossier in three to four weeks 01 ### Scope Tell us the supplier and the product. We confirm a fixed fee before we start. 02 ### Verify We check registers, certificates and evidence, and label every fact. 03 ### Share You receive the dossier, and buyers can confirm it with us. Our promises - A fixed fee, agreed before we start - Results cannot be bought or edited - Our commercial interest is always disclosed - Shared only with your consent The steps in detail 1. 01 Intake and identity checks on both client and supplier 2. 02 Register, certificate and ESG rating checks 3. 03 Supplier questionnaire and evidence, including ESG, supported in English, Chinese or Korean 4. 04 Review and labelling of every item 5. 05 Optional site visit, recorded as facts 6. 06 Review by a senior quality and regulatory specialist before release 7. 07 Release, with an optional yearly refresh Clear about limits ## What a dossier is not A GSV dossier is not an audit, an inspection, a certification or an approval of the supplier. It does not state that a supplier complies with ISO 13485, GMP or the MDR, and it does not replace the buyer's own supplier qualification. Aurienta is not a certification or inspection body. The value is in facts anyone can re-check, disclosed early and in one place. Fit ## Is a dossier right for you? ### A good fit if - You make medical device components, materials, finished devices, aesthetic products or pharma ingredients in China or Korea, and want European device makers, pharma companies or distributors as customers - You are an EU buyer or start-up comparing suppliers before ordering samples - You need supplier ESG evidence for your own sustainability reporting or due diligence - You are ready to be open about your company, sites and quality system ### Not a fit if - You are looking for a certificate or badge. A GSV dossier is an evidence file, not a certificate - You need ISO 13485, GMP or CE certification itself. For that you need a certification body or notified body. - You need an ESG rating itself. We check and document the rating a supplier has; we do not issue one Questions ## Good to know ### Can a supplier pay for a positive result? No. Our fee is agreed before we start and does not depend on the outcome. The supplier sees the findings and can close gaps, but cannot edit them. That is why buyers can rely on the dossier. ### Can buyers check a dossier with you? Yes. With the consent of the party that commissioned it, we confirm to a buyer that a dossier is genuine and which date it reflects. ### Who sees the dossier? The party that commissions it decides. A supplier shares it with the buyers it chooses. We never pass it on without consent. ### How long is a dossier valid? It reflects the supplier on the date of our checks. We recommend a yearly refresh, or an update after a change of site, ownership or certification. ### Do you cover ESG, such as EcoVadis? Yes. We record which ESG ratings, certificates and audits a supplier has, check them with the platform or issuer, and show the gaps a buyer will ask about. We do not issue an ESG rating ourselves. ### We do not have an EcoVadis rating yet. Can you help? Yes. We help suppliers prepare for an EcoVadis assessment and put their sustainability documentation in order, so the dossier is complete before buyers ask. This support is stated in the dossier and does not change how we label the facts. What is at stake ## Two ways this can go If nothing changes - Gaps appear in the buyer’s audit, after the samples, the trials and the budget are spent - Suppliers answer the same questions for every buyer, and still wait With a GSV dossier - **For suppliers:** European buyers open your dossier, check the facts and order samples - **For buyers:** you start development with a supplier you know, not one you hope for ## Start with one supplier Tell us the supplier, the product and the market. We'll scope the right dossier. Talk to us at CPHI Milan. We speak English, Chinese and Korean. [Discuss a dossier](https://www.aurientalife.com/cphi-milan?hsLang=en)[info@aurientalife.com](mailto:info@aurientalife.com) ![Aurienta Life Sciences](https://www.aurientalife.com/hubfs/aurienta-logo-reversed.png) The Europe–Asia life sciences bridge. Supplier due diligence, market entry and two-way distribution for medtech and pharma. #### Services [Supplier Verification](https://www.aurientalife.com/gsv?hsLang=en)[Market Entry](https://www.aurientalife.com/market-entry?hsLang=en)[Distribution](https://www.aurientalife.com/distribution?hsLang=en) #### Company [About](https://www.aurientalife.com/about?hsLang=en)[CPHI Milan 2026](https://www.aurientalife.com/cphi-milan?hsLang=en)[Privacy policy](https://www.aurientalife.com/privacy-policy?hsLang=en)[GDPR policy](https://www.aurientalife.com/gdpr-policy?hsLang=en) #### Contact [info@aurientalife.com](mailto:info@aurientalife.com)Amsterdam, the NetherlandsShanghai, China © 2026 Aurienta Life Sciences B.V. (in formation), AmsterdamConnecting markets. Advancing life.