Regulatory Translations

CSOFT’s regulatory translations help companies in the life sciences and other highly regulated industries compete and succeed in new markets

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Regulatory Translations

Regulatory translations, referring to linguistic translations of regulatory submissions, comprise a vital step toward market access for companies engaging a diverse range of industries and regulatory environments with distinct requirements for language inclusion. From virtually all sectors of the life sciences, to the global financial, energy, and vehicle manufacturing industries, consistently and accurately localizing regulatory documentation is a constant challenge companies face in securing opportunities for growth in foreign markets, as well as domestic markets where multilingual documentation is mandatory.

With a global network of 10,000+ linguists and industry regulation subject matter experts, and with coverage for over 250 languages, CSOFT offers end-to-end regulatory translation services for a full range of industries and sectors, including:

Document types that we specialize in localizing include:

Dossiers
Exposure Scenarios
Safety Data Sheets (SDSs) / Extended Safety Data Sheets (eSDSs)
Material Safety Data Sheets (MSDSs)
Summary of Product Characteristics (SPCs)
Labels and Packaging
Engineering Manuals
Registration Documents
Clinical Study Documentation
Manufacturing SOPs

In addition to standard services for regulatory translations, CSOFT offers certified translations for regulatory documents that require a certificate of accuracy at the time of submissions. Learn more about our certified regulatory translation here.

Health and Medical Regulatory Translations for All Phases of the Product Lifecycle

While regulatory translations are mandatory for a variety of product types, few industries rival the life sciences in their demand for formal documentation. By the same token, there is virtually no analogy in other industries for the rigorous global submission process that pharmaceuticals, CROs, and medical device manufacturers routinely encounter in the course of developing and marketing new treatments. As focus grows around diversity in clinical trials, and as global regulatory bodies update their requirements for market entry under new guidelines, medical regulatory translations are an ever-increasing focus area for medical products requiring expert language service support. CSOFT’s localization support for regulatory affairs extends across a full range of document types, including:

Common Technical Document (CTD/eCTD)Translations
Instructions for Use (IFU) Translations
Package Information Leaflets (PILs)
Labeling
Material Safety Data Sheets (MSDS) / Safety Data Sheets (SDS)
Summary of Safety and Clinical Performance (SSCP)
Summary of Product Characteristics (SmPC)
AEs/Ars/SAEs/SUSARs (IEB/IRB Correspondences)
Chemical, Manufacturing, and Control Documents (CMC)
Investigator Brochures (IBs)
Informed Consent Forms (ICFs)
Risk Management Plans (RMPs)
Clinical Study Reports (CSRs)
Dossiers

Learn more about CSOFT’s life sciences regulatory translations here.

Navigating Regulations for Transportation and Vehicle Manufacturing through Translation

For companies providing transport solutions over land, air, and sea, distinct regulatory concerns directly impact their viability in domestic and global markets, in many cases requiring that they invest in multilingual translations for their regulatory content. Today, many of the same considerations now extend to aerospace travel regulations. Whether documenting compliance with market specifications for vehicle manufacturing, air travel regulations, or marine transport, CSOFT can help companies localize their products and services for international markets through high quality regulatory translations.

Learn more about our transportation regulatory translations here.

Financial Regulatory Translations for International Banking and Capital Markets

National economies and financial environments are both highly regulated and highly distinct from region to region of the globe, making financial regulatory translations essential to success in a variety of ventures. From accounting and mergers and acquisitions, to insurance and retail banking, CSOFT can help companies and groups ensure compliance through consistent, accurate financial document translations. Learn more here.

Quality Assurance

Professional, high-quality localization of a service or product is critical for translation solutions in global markets. CSOFT understands the importance of accurate translation, which is why we have developed a process for quality assurance to ensure that any project that is translated meets quality standards in a timely manner that is also cost effective. Our advanced translation technology management system allows for translation projects remain in one centralized location, updated in real time, to ensure CSOFT has you covered every step of the way. Additionally, we are certified in ISO 17100:2015, ISO 9001:2015, and ISO 13485:2016, ensuring our customized solutions meet global regulatory requirements and our clients’ highest expectations for quality.

Learn more about our quality assurance processes.

Data Security

CSOFT has meticulously documented and fully traceable information security policies, checklists, and quality records. We understand the importance of security to our clients, which is why we take the upmost care in protecting patients’ confidentiality, as well as businesses’ data. All our data security processes leverage best practices from ISO 27001, ensuring we adhere to the latest international standards in information security.

Learn more about CSOFT’s data security procedures.

Speak to us today!

For more information on how CSOFT can assist you with your translation requirements, please contact us through this website, or call us at +1-617-263-8950.

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