Professional Language Translation for FDA Submissions
Stepes (/’steps/) provides expert FDA submission translation services in over 100 languages. We help our life sciences clients meet regulatory compliance, secure rapid approval, and accelerate global success, one accurately translated FDA submission at a time.
Accurate FDA Submission Translations You Can Trust
Are you a life sciences manufacturer requiring translations for FDA submissions such as Investigational New Drug Application (IND), New Drug Application (NDA), Drug Master Files (DMFs), or Investigational Device Exemption (IDE) for regulatory approval? Look no further than Stepes. We offer expert translation services for a range of submission documents mandated by the Food and Drug Administration, tailored for companies from non-English-speaking countries or those targeting the global market. With a large team of professional translators and multilingual subject matter experts, we specialize in translating FDA submissions with the utmost quality and efficiency.
Professional FDA submission translations demand the most rigorous language translation processes, including linguistic validation, back translation, and cognitive debriefing. Stepes possesses the linguistic experience and localization methodologies to translate FDA submissions that adhere to industry standards without sacrificing efficiency. Furthermore, we leverage the latest language technologies to streamline the translation process, ensuring unrivaled linguistic consistency and technical accuracy. Speak with a Stepes FDA submission translation consultant today and discover how we can elevate your multilingual regulatory performance to a higher level of international ROI (return on investment).
We Translate All FDA Submissions
Stepes has the linguistic experience and localization best practices to provide accurate translations for a comprehensive range of FDA submissions intended for regulatory approval. Below is a list of submission documents we regularly handle:
- Investigational New Drug Application (IND): This document that, once translated, is required before a new drug undergoes human testing.
- New Drug Application (NDA): Manufacturers submit this document for the approval of new drugs for the U.S. market, and it often requires translation to facilitate international communications.
- Biologics License Application (BLA): We translate this application for entities seeking to introduce or deliver a biologic product into interstate commerce.
- Abbreviated New Drug Application (ANDA): We handle translations related to the approval process of generic drugs.
- Premarket Approval (PMA): Essential translations needed to secure clearance for high-risk medical devices.
- Premarket Notification (510k): Translations for premarketing submissions made to demonstrate a medical device’s safety and effectiveness.
- Drug Master Files (DMFs): Comprehensive translations of technical documents containing proprietary information on the manufacturing, processing, packaging, and storing of human drugs.
- Master Access Files (MAF): We translate these files designed for devices, which house information that can support various submissions.
- Investigational Device Exemption (IDE): Translations are critical for studies testing unapproved medical devices.
- Emergency Use Authorization (EUA): Translations aid in the swift facilitation of medical countermeasures during public health emergencies.
- Supplements: We translate supplements such as Changes Being Effected (CBE), Prior Approval Supplements (PAS), and Annual Reports detailing changes to approved applications.
- Adverse Event Reports: Crucial translations of reports noting unfavorable events related to drug or medical device use.
- Labeling, Promotional Material, and Advertising Submissions: Translations are vital for materials intended for both consumers and healthcare professionals across linguistic barriers.
- Quality System/Good Manufacturing Practice (GMP) Documentation: We provide translations of quality records and reports, ensuring clarity during FDA inspections.
- Establishment Registration and Product Listing: We translate details for facilities engaged in producing and distributing FDA-regulated products.
- Pediatric Study Plans (PSP): Translations of plans detailing drug assessments potentially used for children.
- Risk Evaluation and Mitigation Strategies (REMS): Our translations clarify strategies ensuring a drug or biological product’s benefits outweigh potential risks.
Industry Expertise
At Stepes, we pride ourselves on employing translators with both linguistic capabilities and subject matter expertise in the pharmaceutical, biotechnology, and medical device sectors to translate our clients’ FDA submissions. Our rich portfolio of case studies attests to our unparalleled industry experience and successful project outcomes.
Quality Assurance
Stepes adheres to globally recognized industry standards, underscored by our ISO certifications. Our multi-stage review processes involve senior translators and industry experts who leverage Stepes’ best practices in translation. Further, our efficient use of Translation Memory (TM) and continuous terminology management tools ensures the highest level of linguistic quality output.
Data Security and Confidentiality
Recognizing the highly sensitive nature of FDA submissions, Stepes has implemented rigorous data protection and confidentiality protocols. We employ secure file transfers enhanced by top-tier data encryption techniques, ensuring that every document remains confidential. This trust is further bolstered by our strict non-disclosure agreements with our dedicated translators. With Stepes, you can have complete peace of mind, knowing that your information is protected at every step of the translation process.
Regulatory Knowledge
Stepes possesses in-depth experience in translating for regulatory affairs and compliance requirements. Our professional linguists are not only linguistically proficient but also specially trained to produce translations that align with FDA regulations and guidelines. We take meticulous care to ensure your submission translations meet the stringent requirements of the FDA. To further support this expertise, our in-house multilingual regulatory consultants are always available to provide insights and guidance.
Transparent Pricing and Timeline
Stepes believes in fostering customer trust through transparency. We offer clear, competitive pricing structures without hidden costs, and our clients always receive a detailed breakdown of project timelines.
Linguistic Validation Services
Stepes provides professional linguistic validation services to meet our clients’ regulatory submission translation requirements. Certain FDA submission documents are particularly sensitive due to their direct impact on patient safety, comprehension, and therapeutic outcomes. These documents necessitate a more rigorous translation process, often involving linguistic validation, to ensure that the translated content is not only accurate but also culturally appropriate, comprehensible, and conceptually equivalent to the original.
Stepes has in-depth experience translating the following FDA submission documents that typically require linguistic validation:
- Patient-Reported Outcomes (PRO): These are questionnaires or tools used in clinical trials to capture patients’ perceptions of their health and the effects of treatments. Ensuring the translated version captures the same meaning as the original is crucial.
- Clinical Outcome Assessments (COA): These documents measure patients’ symptoms, overall mental state, or the effects of a disease or condition on how the patients function.
- Electronic PRO (ePRO) Instruments: The digital versions of PROs also need to undergo rigorous validation to ensure that the digital format doesn’t compromise the instrument’s clarity and meaning.
- Quality of Life Questionnaires: These assess a patient’s general well-being and are frequently used in clinical trials to understand the broader impacts of treatments.
- Informed Consent Forms: Essential for any clinical trial, these documents must be clear and comprehensible to participants from different linguistic and cultural backgrounds.
- Patient Information Leaflets (PIL): These accompany medication and provide essential information to the patient. Their translation needs to be accurate and easily understood by a layperson.
- Labeling, Promotional Material, and Advertising Submissions: Especially when these materials are patient-facing, they must be translated with the utmost care to avoid misrepresentation or misunderstanding.
- Risk Evaluation and Mitigation Strategies (REMS): Since REMS is designed to communicate risks, the translation must be precise and undergo rigorous validation.
- Instructions for Use (IFU) for Medical Devices: Ensuring patients and healthcare professionals understand how to use a device properly is crucial for safety.
Stepes’ linguistic validation involves forward translation, reconciliation, back translation, cognitive debriefing with target language speakers, and finalization to ensure the translation is accurate, comprehensible, and culturally adapted for the intended audience. To learn more about our linguistic validation solutions, please click here.
Submissions Expertly Translated in Over 100 Languages
Stepes boasts one of the largest teams of professional life sciences translators, covering all major European, Asian, and Latin American languages. Below is a list of languages in which we provide FDA submission translation services.
- Arabic (AR)
- Chinese, Simplified (ZS)
- Czech (CS)
- Danish (DA)
- Dutch (NL)
- English (EN)
- English, UK (UE)
- Finnish (FI)
- French (FR)
- German (DE)
- Italian (IT)
- Japanese (JA)
- Korean (KO)
- Norwegian (NO)
- Polish (PL)
- Portuguese, Brazilian (PB)
- Russian (RU)
- Spanish (ES)
- Swedish (SV)
- Thai (TH)
- Vietnamese (VI)
- Afrikaans (AF)
- Albanian (SQ)
- Amharic (AM)
- Armenian (HY)
- Azerbaijani (AZ)
- Basque (EU)
- Belarusian (BE)
- Bengali (BN)
- Bhutanese (BT)
- Bihari (BH)
- Bosnian (BS)
- Breton (BR)
- Bulgarian (BG)
- Burmese (MY)
- Catalan (CA)
- Chinese, Hong Kong (ZH)
- Chinese, Traditional (ZT)
- Croatian (HR)
- English, Australian (AE)
- English, Canadian (CE)
- Estonian (ET)
- Faroese (FO)
- Filipino (TL)
- French, Canadian (CF)
- Frisian (FY)
- Galician (GL)
- Georgian (KA)
- Greek (EL)
- Guarani (GN)
- Gujarati (GU)
- Hausa (HA)
- Hawaiian (HW)
- Hebrew (IW)
- Hindi (HI)
- Hungarian (HU)
- Icelandic (IS)
- Igbo (IG)
- Indonesian (ID)
- Interlingua (IA)
- Irish (GA)
- Javanese (JW)
- Kannada (KN)
- Kashmiri (KS)
- Kazakh (KK)
- Khmer (KM)
- Kirundi (RN)
- Kurdish (KU)
- Laothian (LO)
- Latin (LA)
- Latvian (LV)
- Lingala (LN)
- Lithuanian (LT)
- Luganda (LG)
- Macedonian (MK)
- Malagasy (MG)
- Malay (MS)
- Malayalam (ML)
- Maltese (MT)
- Maori (MI)
- Marathi (MR)
- Moldavian (MO)
- Mongolian (MN)
- Montenegrin (ME)
- Nepali (NE)
- Norwegian Nynorsk (NN)
- Pashto (PS)
- Persian (FA)
- Persian, Dari (DR)
- Portuguese (PT)
- Punjabi (PA)
- Romanian (RO)
- Rwandan (RW)
- Scots Gaelic (GD)
- Serbian (SR)
- Sesotho (ST)
- Shona (SN)
- Slovak (SK)
- Slovenian (SL)
- Somali (SO)
- Spanish, Latin American (XL)
- Sundanese (SU)
- Swahili (SW)
- Tajik (TG)
- Tamil (TA)
- Tanchangya (TC)
- Telugu (TE)
- Tibetan (BO)
- Tonga (TO)
- Tswana (TN)
- Turkish (TR)
- Uighur (UG)
- Ukrainian (UK)
- Urdu (UR)
- Uzbek (UZ)
- Valencian (VA)
- Welsh (CY)
- Yiddish (YI)
- Yoruba (YO)
- Zulu (ZU)
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