Polish translation for life sciences, audited for the regulator on the other end
Polish life sciences translation is the regulated translation of clinical, pharmaceutical and medical-device content into native Polish (PL-PL), performed under ISO 17100:2015 with ISO 13485:2016-aligned procedures for medical devices. Built for pharma sponsors, CROs, MAHs, MedTech manufacturers and IVD companies whose Polish documentation has to pass URPL, EU centralised submission and notified-body audit on the first round.
Life sciences translation is regulated work. Polish makes it more regulated.
Polish life sciences translation is the conversion of clinical, pharmaceutical, medical-device and IVD content into native Polish (PL-PL) by linguists with documented backgrounds in medicine, pharmacy or biomedical sciences, then revised independently under ISO 17100:2015 and produced under ISO 13485:2016-aligned procedures for medical-device documentation.
It is not the same as general translation: every regulator (URPL, EMA, ethics committees, notified bodies) has terminology expectations the source-language editor never sees, every clinical-trial document has a back-translation and reconciliation pathway, and any document that touches a Polish authority needs sworn certification (tłumaczenie przysięgłe) by a translator on the Polish Ministry of Justice register.
Aploq translates the full regulated set: ICFs (with back-translation), IBs, CSRs, CIOMS-I, SUSAR reports, SmPCs, PILs, RMPs, IFUs, CIPs, EU MDR Annex I labelling, IVDR clinical evaluation reports, and patient-facing material for ethics-committee submission.
Five life-sciences buyer types, paired by therapeutic area
Different sub-domains of life sciences need different linguist backgrounds. We pair every project with a Polish-native medical linguist whose subject-matter expertise matches the document set.
Every Polish-market life-sciences document we translate
From a single SUSAR report to a 200,000-word IND/IMPD package. The label tells you the relevant authority or clinical use case.
Document type you don’t see? Send the file. Polish-market life-sciences work runs from a 1-page SUSAR through a 200,000-word IND/IMPD submission — we route to the right specialist within an hour.
Six regulatory frameworks that shape every Polish life-sciences project
Polish life-sciences translation isn’t free-form. Six frameworks set the terminology, the workflow, and the certification path. We map your document to the relevant one before translation begins.
EU MDR (EU 2017/745)
The EU Medical Device Regulation requires patient-facing labelling and IFUs in the official language of every Member State where the device is placed on the market. Polish text must be on the device, not in a separate leaflet, for many classes. Our medical-device linguists translate to Annex I requirements with notified-body audit in mind.
EU IVDR (EU 2017/746)
The In-Vitro Diagnostic Regulation adds clinical evaluation, performance evaluation and post-market surveillance requirements that didn’t exist under the previous IVDD. Polish translations of clinical evaluation reports and IFUs are increasingly scrutinised in notified-body submissions. Aligned with ISO 13485 + ISO 14971.
ICH E6(R3) Good Clinical Practice
The 2024 ICH GCP revision strengthens the integrity, transparency and patient-centricity expectations for clinical trials. Translation of trial documentation — protocols, ICFs, IBs — is explicitly within scope. ICF readability for Polish patients is a regulator focus area.
EMA centralised submissions
For products approved via EMA centralised procedure, the SmPC, PIL, RMP and labelling must be translated into all 24 EU languages — including Polish — to QRD template and EMA terminology. We translate to the EMA QRD-template style guide; terminology aligned with MedDRA and EDQM.
URPL & Polish authorities
The Polish Office for Registration of Medicinal Products, Medical Devices and Biocidal Products (URPL) accepts sworn (przysięgłe) Polish translation by translators on the Polish Ministry of Justice register. We deliver in the format URPL expects, including the QES (qualified electronic signature) for digital submissions.
Polish ethics committees
Polish bioethics committees (komisja bioetyczna) require submission packages in Polish, with sworn certification on the patient-facing materials and ICFs. Each major Polish university hospital and academic medical centre has its own committee with its own template requirements; we keep the format library current.
Six steps from brief to a Polish submission package
The same workflow whether the source is a single SUSAR or a full IND/IMPD package. ISO 17100 four-eyes is the baseline; ISO 13485-aligned procedures kick in for medical-device documentation.
Quote & pairing
Source files, deadline, target authority (URPL, EMA, EC, NB) and therapeutic area in. Fixed-price quote within 1 EU business hour.
Termbase prep
Client TM and termbase loaded. MedDRA / EDQM / IATE alignment. Brand-name handling locked. Sworn-translator pairing where required.
Native PL-PL translation
Translation by a Polish-native medical linguist with documented therapeutic-area expertise. Trados / MemoQ / Phrase native.
ISO 17100 revision
Independent native Polish reviser checks against source, terminology, regulatory style guide, and authority-specific format requirements.
Back-translation (ICF)
For ICFs and patient-facing material: blinded back-translation by a third linguist + senior-reviser reconciliation against the source.
Submission-ready
Final-eye proof. Sworn certification with QES if URPL/EC bound. Delivery in source format with audit trail and certificate.
Three engagement models for life-sciences buyers
From a single SUSAR through a multi-year clinical programme. ISO 17100 + ISO 13485-aligned procedures are baseline on every tier.
Where to go next, by what you need translated
Polish life-sciences work usually pulls in two or three sibling services. Here’s where they live.
Life-sciences questions
The eight questions sponsors, CROs and MedTech buyers ask before signing.
We translate the full regulated document set: Informed Consent Forms (ICFs), Investigator Brochures (IBs), Clinical Study Reports (CSRs), CIOMS-I forms, SUSAR reports, Summaries of Product Characteristics (SmPCs), Patient Information Leaflets (PILs), Risk Management Plans (RMPs), Instructions for Use (IFUs), Clinical Investigation Plans (CIPs) and EU MDR Annex I labelling. We sworn-translate documents headed for URPL, Polish ethics committees and EU centralised submissions where certification is required.
Yes. Aploq operates under ISO 13485:2016-aligned procedures for medical device documentation, in addition to ISO 17100:2015 certification for translation services. This means documented translator qualifications, controlled terminology management, traceable revision records, and a quality framework that aligns with notified-body audit expectations. Certificate copies are available to clients on request.
Yes. ICF back-translation is a routine deliverable. The workflow is: (1) forward translation by a Polish-native medical linguist; (2) independent revision under ISO 17100; (3) blinded back-translation into the source language by a different linguist; (4) reconciliation against the source by a senior reviser; (5) sponsor or ethics-committee delivery. Standard turnaround for a 6-page ICF is 5–7 EU business days end-to-end.
Yes. EU Medical Device Regulation (EU 2017/745) Annex I requires patient-facing labelling and instructions for use to be in the official language of each EU member state where the device is placed on the market. Our medical device linguists translate IFUs, Patient Information Leaflets, Declarations of Conformity, and CE marking documentation into Polish for notified-body submission and URPL registration. Procedures align with ISO 13485:2016 and ISO 14971:2019 (risk management for medical devices).
For Polish-market clinical trials we translate the full ICH GCP documentation set into Polish: protocols, amendments, ICFs (with back-translation and reconciliation), IBs, CSRs, SAEs / SUSARs, CIOMS-I forms, patient-facing material, ethics-committee submissions, and Polish CTA (Clinical Trial Application) packages. Sworn certification is added on request for URPL and ethics-committee submissions. Specialist linguists are paired by therapeutic area (oncology, cardiology, neurology, immunology, etc.).
Polish is our specialism (PL-PL into and out of). We translate from English, German, French, Italian, Spanish and Dutch into Polish for life sciences clients across pharma sponsors, CROs, MAHs and medical device manufacturers. For other languages required by EU centralised submissions (24 EU languages total), we coordinate via vetted partner medical linguists while keeping project management, terminology and QA in-house.
Standard turnaround is 1,500–2,500 source words per business day per medical linguist. A typical 5,000-word document (ICF, IB, CIOMS-I) takes about 3 EU business days end-to-end including ISO 17100 revision. Express turnaround within 24–48 hours is available for urgent SUSAR reports, ethics-committee deadlines and regulatory queries. For large CSR or IND/IMPD submission packages (50,000+ words), we run paired translators with a senior medical reviser maintaining consistency.
Life sciences translation under ISO 17100 + ISO 13485-aligned procedures typically ranges from €0.14/word for general medical content to €0.20/word for clinical trial / regulatory submission content. Sworn translation is priced per certified page (€15–25 per 1,125-character page). ICF back-translation + reconciliation is priced at +30% of the forward-translation rate. Volume discounts apply over 10,000 words. Express turnaround within 24–48 hours adds a 50% surcharge.
Send the regulated file. One hour, one Polish quote.
Source language, target authority (URPL / EMA / EC / NB), therapeutic area, deadline. Mutual NDA standard before any file leaves your side.
