FAQ

Our vast network of over 3500+ expert medical translators allows us to accommodate large projects with quick turnaround needs. We do this by customizing the project and assigning it to a specially curated team, using our learnings on other successful projects.  

To streamline this process, we’ve built a portal where Project Managers can very quickly post new projects, receive applications from over 3000 medical professionals, review translators ́ profiles based on professional/educational background, services and specializations, feedback on their work, etc. and hire the best candidates according to project requirements. The platform provides a central place where PMs can have real-time access to their projects, communicate with hired translators, store/exchange files via a secured system, etc.

We do! All our operations are compiled in SOPs, that are updated on a regular basis so we can maintain complete consistency.

Our vendor team carefully screens each experts background and credentials and will verify that they comply with our following minimum requirements:  

• a scientific background (MSc, PharmD, PhD, MD) and/or a Master´s Degree in Translation with specialization in the medical field  
• certification by an accredited translation and/or medical writing organization  
• senior experience in medical translation  

New translators are being tested on sample translations in their field(s) of specialization by our senior medical proofreaders. Those who meet the industry quality standard are registered in our system so that our project managers can search/contact these specialists based on the following filters: 

• Specialized service (e.g. medical translation, medical writing, regulatory affairs, etc.)  
• Languages (if translation selected)  

Field of specialization (e.g. pharma, medical device, biotechnology, veterinary, etc.)  

• Therapeutic area (e.g. immunology, vaccines, etc.)  
• Document type (e.g. SmPC, ICF, IFU, PROs, Product Monograph, etc.)  
• Country 

For Translation Memory management, we uses Trados Studio (current version 2019). For each client, we create a specific TM for each language pair that is updated on a project basis upon translation finalization, to keep terminology and stylistic consistency for future translations.

Of course,  we fully train our Projects Managers and translators on client’s processes and software. We usually create client specific SOPs and strictly follow them for all client’s specialized projects.

We use very strict QA/QC procedures – in full compliance with ISO 17100 and EN 15038 translation quality standards -, including: 

• Translation by a senior medical translator 
• Proofreading/editing by a second qualified translator

We exceed those standards by adding the following quality steps:

• Revision and validation of any changes by the original translator 
• Accuracy and compliance review by an in-house validator 
• Confirmation of any doubts/comments with the translation team, if any exist 
• Final review by a Novalins project manager specialized in regulatory submission 
• Delivery of final translations with a certificate of accuracy

It is also possible to adapt our processes and add additional quality steps such as back-translation if this is needed. For customers who require different processes that are more adapted to their documents and/or sector, we can create personalized QA/QC processes which would be systematically followed by our teams. We have created personalized processes for several companies, mainly for medical app/software organizations, who needed to include additional pre-/post-translation steps.

Upon client’s needs (usually for clinical trials materials), we can integrate back-translation in our processes, which includes:

• Forward translation by one senior medical translator (native speaker of the target language)
• Back translation by another senior medical translator (native speaker of the source language)
• Reconciliation/review of both translations (forward and back) to check for any discrepancies
• In case of discrepancies, discussion between the reviewer and the forward translator and update of the translation if necessary
• Proofreading of the translation to reach a final version
• Accuracy and compliance review by in-house validators
• Final review by a Novalins project manager specialized in the medical field

We regularly provide a ‘forward and back’ translation service, which is an integral part of our QA/QC processes for the “Translation and Linguistic Validation of Patient Reported Outcomes (PROs)”. 

We’ve also provided ´back´ translation services for regulatory materials such as SmPCs, usually from EU languages to English. We normally submit a reconciliation report to help translation teams refine and make adjustments to their final translation. 

We can provide this service from all EU languages into English, and vice versa.

All our final translations are delivered with a Translation Certificate of Accuracy, which guarantees your specialization in the medical field, the QA/QC processes were followed (ISO 17100 and EN 15038 translation quality standards), as well as verification our expert’s credentials.

Yes, we do have a professional insurance.

We collaborate solely with in-country experts who combine a strong scientific/medical background (qualified medical professionals), senior experience in medical translation, with strong knowledge of local/regulatory requirements. 

They all meet the following credentials:   

• A scientific background (MSc, PharmD, PhD, MD) and/or a Master’s Degree in Translation with specialization in the medical field   
• Certification by an accredited translation and/or medical writing organization   
• Senior experience in medical translation
• Native in the target language

We are proud to include in our team: 

• 600 medical doctors and 900 PhDs specialized in a broad range of therapeutic areas  
• 400 professionals with clinical, quality, and regulatory experience in the Medical Devices industry  
• 70 former agency reviewers and inspectors (EU countries, the United States, Canada, Brazil, India)

We work exclusively for the healthcare sector and have extensive experience with clinical research and regulatory documentation for health authorities (EMA, Health Canada, US FDA submission and national health authorities).  

We offer a Regulatory Approval Guarantee and will provide a Translation Certificate of Accuracy with detailed information about our QA/QC processes and experts ́ credentials, upon project finalization.  

To meet this level of services, we collaborate solely with in-country experts who combine a strong scientific/medical background (usually medical doctors), senior experience in medical translation, and strong knowledge of local/regulatory requirements.  

For regulatory materials, we collaborate with translators who possess a combined background in both pharma transition and regulatory affairs. For EMA projects, we have a total of 1,800 EU-based senior pharma translators (an average of 50 in-country specialists for each European language).

We translate mainly technical, clinical and regulatory materials including but not limited to Instructions for use (IFUs), Directions for use (DFUs), Packaging inserts and Labelling, Software user interfaces, Laboratory manuals and protocols, Case report forms, Data protocols from clinical research, Clinical study results, Informed consent forms, SOPs, and Questionnaires.

We provide high-end translation services to demanding medical devices, pharmaceutical, e-health companies and other healthcare organisations.   

Thanks to our vast network of in-country scientific experts, we can cover all major fields of expertise and therapeutic areas in over 120 languages  

Through the years, we’ve developed extensive experience in the translation of medical apps and software, medical reports/diagnostics (second opinion), as well as with clinical research and regulatory documentation for health authorities (EMA, Health Canada, US FDA submission and national health authorities).

To become a Novalins ́ Translator, each experts background and credentials are carefully screened by our vendor team who verifies that they comply with our following minimum requirements:  

• Ascientific background (MSc, PharmD, PhD, MD) and/or a Master’s Degree in Translation with specialization in the medical field  
• Certification by an accredited translation and/or medical writing organization  
• Senior experience in medical translation  

We are proud to include in our team: 

• 600 medical doctors and 900 PhDs specialized in a broad range of therapeutic areas  
• 400 professionals with clinical, quality, and regulatory experience in the Medical Devices industry  
• 70 former agency reviewers and inspectors (EU countries, the United States, Canada, Brazil, India)

For EMA-regulatory translations, we have a total of 1,800 EU-based pharma translators (an average of 50 in-country specialists for each European language). All Project Managers and translators working on regulatory materials have a solid understanding of EMA requirements in terms of layout/format (QRD template), terminology standards (medDRA and EDQM), style, readability and content.   

They are aware of the latest standard headings and phrases that are published by the EMA-QRD group. For EMA-regulatory translation, we usually collaborate with translators who possess combined background in both medical transition and regulatory affairs.  

We’re committed to providing EMA/FDA and national health authorities-compliant translations, on time, which can be testified in the recommendation letters prepared by some of our regular pharmaceutical clients. We would be happy to provide further referrals, if you feel this is necessary.

We would be happy to provide further referrals upon request

On a daily-basis, we provide EMA-compliant translation in all EU languages for various MAAs: Centralized Procedure (CP), Decentralized Procedure (DCP), Mutual Recognition Procedure (MRP), Referral Procedure and Type IA/IB and Type II Variations.   

We translate active substances and proposed indications in all 24 EU languages for orphan drug designations, as well as regulatory compliance checks of label translations.    Note that for EMA-regulatory translations, we have a total of 1,800 EU-based pharma translators (an average of 50 in-country specialists for each European language).

For the past 2 years, we have successfully fulfilled hundreds of EMA-compliant translations in all EU languages for various MAAs: Centralized Procedure (CP), Decentralized Procedure (DCP), Mutual Recognition Procedure (MRP), Referral Procedure and Type IA/IB and Type II Variations.  

When translating in a Centralized Procedure setting, we commonly translate a pre-final version of the text ahead of time. This strategy guarantees that our customers’ country offices have sufficient time to evaluate the translations. After Day 210 of the procedure, when we receive the final changes in the EN texts from the client, the remaining five-day period provides the opportunity for us to implement these changes.

Quote preparation is within 24 hours (maximum), even though it is usually submitted the same day. Urgent requests can be treated with priority and provided in a few hours.

For small documents, our minimum turnaround time is two business days, as we need enough time to strictly follow our QA/QC procedures.   

One translation team (translator, proofreader, QA checkers) can translate a volume of 1600 words per day. For urgent projects, and thanks to our large network, we can set up several teams to work in parallel, if needed. For instance, we delivered a 30,000-word translation in one week for an urgent regulatory submission.  

For customers who require quicker deliveries for regular translation projects, we could agree on an improved turnaround time. 

Our vast network of over 3500+ expert medical translators allows us to accommodate large projects with quick turnaround needs. We do this by tailoring the project and assigning it to a specially curated team, using our learnings on other successful projects.    

To streamline this process, we’ve built a portal where Project Managers can very quickly post new projects, receive applications from over 3000 medical professionals, review translators ́ profiles based on professional/educational background, services and specializations, feedback on their work, etc. and hire the best candidates according to project requirements. The platform provides a central place where PMs can have real-time access to their projects, communicate with hired translators, store/exchange files via a secured system, etc. 

We have extensive experience with pharma-regulatory translation and can translate the Product Information in all 24 EU languages within 5-day slot set by the EMA, thanks to our network of 1,800 EU-based senior pharma translators (an average of 50 in-country specialists for each European language). They all have a solid understanding of EMA requirements in terms of layout/format (QRD template), terminology standards (medDRA and EDQM), style, readability and content.  

When translating in a Centralized Procedure setting, we commonly translate a pre-final version of the text ahead of time. This strategy guarantees that our customers’ country offices have sufficient time to evaluate the translations. After Day 210 of the procedure, when we receive the final changes in the EN texts from the client, the remaining five-day period provides the opportunity for us to implement these changes.

We can send our MSA upon request and depending on the level of changes, and it can take up to a couple of weeks until signature.

We’ve developed 2 software – a Project Management and a Clients ́ Portal – which facilitate and automate many of the communication requirements associated with urgent and regular translation projects:

PROJECT MANAGEMENT PORTAL 

We have built a portal where Project Managers can very quickly post new projects, receive applications from translators, review translators ́ profiles (professional/educational background, services and specializations, feedback on their work, etc.) and hire the best candidates according to project requirements. The platform provides a central place where PMs can have real-time access to their projects, communicate with hired translators, store/exchange files via a secured system, etc. 

CLIENTS ́ PORTAL

We have created an online Portal to respond to Life Sciences companies ́ demand for real-time access to their projects and billing information. As well as providing a secure and HIPAA compliant store/exchange file system, it also centralizes all translation activities with one provider. Imagine a customized portal, where all your colleagues from all operating offices can place orders in one place. This technology automates and facilitates the coordination of large-scale and regular translation projects.

We have developed an API we could use to connect with our clients ́ platform.

We’ve created a uniquely tailored online Portal to respond to Life Sciences companies ́ demand for real-time access to their projects and billing information. As well as providing a secure and HIPAA compliant store/exchange file system, it also centralizes all translation activities with one provider. Imagine a customized portal, where all your colleagues from all operating offices can place orders in one place. This technology automates and facilitates the coordination of large-scale and regular translation projects.

• Is it possible to request new features on your portal?
• Can we have multi-users working simultaneously on your portal?
• Is there a fee to use your portal?

For Translation Memory management, we use Trados Studio (current version 2019). For each client, we create a specific TM for each language pair that is updated on a project basis upon translation finalization, to keep terminology and stylistic consistency for future translations.

All our medical translators and experts work under binding non-disclosure agreements. 

We are registered with the local data protection organization and is up-to-date with GDPR requirements.  Our teams receive on-going training sessions from our data privacy consultant to keep up to date with GDPR requirements. We anonymize personal data before sharing any document with our translation teams and re-insert all data back, before delivery of the final translation Our portals are integrated with an online sharing/storage system that are fully HIPAA and Data Protection compliant.