As drugs in pharmaceutical markets continue to expand worldwide, pharmacology translations are essential to ensure proper documentation of drug reactions while complying to regulatory standards. To access foreign markets, instruments such as cryostat, electrode puller, UV spectrometer, and the materials and documents required to operate and sell this equipment must be translated and localized to meet international regulatory standards.
With a global team of in-country linguists and regulatory specialists, CSOFT Health Sciences can help ensure regulatory submission compliance while providing the highest-quality translation and localization solutions across 250+ languages, helping pharmaceutical companies gain market access with confidence. We provide translations for a full range of content, documents, and materials for medical professionals and researchers in the pharmacology field, including:
- Amplifier Rack Translations
- Scintillation Counter Translations
- UV Spectrometer Translations
- Electrode Puller Translations
- Cryostat Translations
- Kymograph Translations
- Histamine Chamber Translations
- Vogel Test Apparatus Translations
- Flame Photometer Translations
- Plethysmograph Translations
- Dissolution test apparatus
- Disintegration test apparatus
CSOFT’s translation and interpreting support enables growing healthcare and research organizations deliver pharmacology solutions across language barriers.
Pharmacovigilance Translations
Within the pharmacological field, pharmacovigilance is a branch of pharmacology that focuses on monitoring, analyzing, reporting, and preventing adverse drug reactions (ADRs), making pharmacovigilance translations a crucial measure to ensuring proper documentation and resolution of such cases. As the global pharmaceutical market shifts overseas, submitting extremely accurate translations of common pharmacovigilance documents like adverse events (AE) and individual case study reports (ICSR) to regulatory agencies on time is critical to protecting consumers worldwide, as well as regulatory approval. With a large network of subject-matter experts (SMEs) and a global network of 10,000+ in-country native linguists, CSOFT Health Sciences offers highly accurate and timely multilingual pharmacovigilance translation and localization solutions in 250+ languages, from DSURS and discharge reports to CIOMs forms and clinical trial documents.
Read more about our pharmacovigilance translations.
Drug Trial Protocol Translations
Drug trial protocol translations are vital when establishing documentation of drug reactions while remaining in compliance with Good Clinical Practice (GCP) guidelines. As the pharmaceuticals industry continues to expand internationally and clinical trials for pharmaceutical products are increasingly conducted overseas, ensuring that all trial procedures adhere to regulatory standards demands high-quality and accurate drug trial protocol translations. Protocols for pharmaceutical products in clinical trials are designed to standardize the study’s objective, design, safety measures, organization, statistical analysis, and other key aspects, to ensure that any replication of the trial can be successful and held to the same standards. To facilitate success in developing new pharmaceutical products and reaching new markets, CSOFT offers high quality and cost-effective translations for drug trial protocols.
Read more about our drug trial protocol translations.
Adverse Event Reporting Translations
With growing focus on monitoring, reporting, and analyzing drug reactions on a global scale, adverse event reporting translations are essential for regulatory compliance and accessing new drug markets. During clinical trials, adverse events (AE), serious adverse events (SAE), and adverse drug reactions (ADRs) are expected to be reported to the regulating agency within specific timelines, which can be as short as 7 days as outlined under FDA regulations for investigational new devices (INDs). Within the pharmacovigilance field, clinical monitoring for all SAEs, ADRS, and AEs is an integral process for ensuring the safety of trial subjects and proving the efficacy of new medical devices and pharmaceutical products. With an increasing number of clinical trials being conducted internationally, providing multilingual adverse event reports and documents is required by many global regulators and is essential for avoiding potentially life-threatening situations. With a global network of linguists and a team of subject matter experts when it comes to pharmacovigilance processes, CSOFT Health Sciences offers fast turnaround times to meet your adverse event reporting translation needs across 250+ languages.
Read more about our adverse event reporting translations.
Anesthesiology Translations
Anesthesiology translations are crucial to provide continuous medical care to patients before, during, and after surgical procedures. To access global markets, instruments such as anesthetic vaporizers, laryngoscopes, and endotracheal tubes along with the materials and documents required to operate and sell this equipment must be translated and localized. CSOFT Health Sciences provides translation and localization solutions tailored for clients worldwide through our global team linguists and medical subject matter experts. We provide translations for a full range of content, documents, and materials for medical professionals in the anesthesiology field.
Learn more about our anesthesiology translations
Quality Assurance
CSOFT Health Sciences has developed a process for quality assurance to ensure that every medical translation project meets quality standards in a cost-effective and timely manner. We are certified in ISO 17100:2015, ISO 9001:2015, and ISO 13485:2016 to ensure our customized solutions meet global regulatory requirements. Our subject matter expert linguists have at least seven years of experience and work with in-country reviewers and project style guides to meet industry standards. CSOFT offers an online translation management ecosystem for one central location to leverage real-time translation memory and terminology management through our innovative cloud-based technology. Every step of the way, CSOFT has you covered.
Learn more about our quality assurance process.
Data Security
With over 20 years of experience in medical translation, CSOFT Health Sciences understands the importance of data security to our clients, and we take nothing for granted when confidentiality is a concern. Our well-documented and fully traceable information data security policies, checklists, and quality records leverage the best practices of ISO 27001. They are designed to protect everything from source data to translations. From our 24/7/365 data monitoring and advanced encryption to our access control measures, you can be sure that your project data is safe from start to finish.
Learn more about how CSOFT prioritizes data security.