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Regulatory Meeting Interpretation

We provide from regulatory interpretation to help medical product companies navigate from the stages of approval through post-launch communication

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Interpretation for Pre-IND/NDA Regulatory Meetings

Life sciences regulatory meetings are increasingly an essential step for gaining approval for new therapies, devices, or products in international markets, and regulatory meeting interpretation can make these meetings accessible to attendees around the world. Regulatory bodies such as the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and China’s National Medical Products Administration (NMPA) regulate the entry of over-the-counter and prescription drugs into regional and local markets, including biopharmaceuticals and other medical products already approved by other regulatory bodies. Pre-investigational new drug/new drug application (Pre-IND/NDA) meetings with local regulatory authorities, such as the FDA, EMA, and NMPA, are crucial for establishing a relationship with regulatory bodies and preparing a medical product for international approval. CSOFT Health Sciences’ expertise in interpreting and medical translation can ensure accurate and timely multilingual communication for every regulatory meeting, no matter what language your company speaks.

Video Remote Interpretation

With a rise in telehealth and remote medical communication solutions, healthcare workers are increasingly turning to solutions like video remote interpretation to connect with their multilingual patients from anywhere in the world. Like OPI, video remote interpretation leverages virtual medical communications while also introducing the added benefit of being able to pick up on body language and facial expressions using videoconferencing technology. In the medical field, video remote interpretation is essential for connecting doctors and other clinicians with limited English proficiency (LEP) patients or to reach patients participating in global sites for clinical trials, and between regulators and their charges. To help facilitate patient-centric medical communications, CSOFT Health Sciences’ professional interpreters offer high-quality and timely video remote interpretation solutions across 250+ languages.

Learn more about our video remote interpretation.

Government and NGO Interpretation

For governmental agencies and NGOs involved with global health, attending, sharing research, and participating in discussions with companies seeking regulatory approval, it is crucial to have interpretation services to communicate across borders. Interpretation is necessary for all stakeholders to access and participate in knowledge sharing.

CSOFT Health Sciences has experience providing simultaneous interpretation for pre- and post-regulatory meetings to ensure that all stakeholders are on the same page.

Learn more about our Government and NGO interpreting services.

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.

High Quality Academic Translations

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.

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