Planning for Your Regulatory Submission
In today’s hyper-globalized world, more and more companies are looking to emerging markets to expand their growth. Let us help with your regulatory submission language requirements for a smooth entry into new markets.
Regulatory submissions for healthcare products requires extensive and complex documentation to be submitted to a regulatory body. Submissions must be submitted in either paper or electronic formats, or a combination of the two. Due to the large volume of documentation, regulatory bodies will often encourage electronic submissions (eCTD). The quantity of multifaceted documentation that is required will vary by the regulatory body involved.
Regulatory documents requiring translation include:
- Instructions for use (IFU)
- CMC documentation
- Case report forms
- Protocols
- Manufacturing procedures
- Design specifications
- Risk assessments
- Bio-compatibility reports
- Clinical trial documentation
- Informed consent forms
CSOFT International has a 6,000-strong network of professional in-country linguists, cultural experts, and the latest language technology that delivers localization solutions for regulatory submissions to expand your global business.
Our methodologies and technology-driven solutions, combined with cost-effective services help leading pharmaceutical and medical device companies save time and cut costs.
Whether it’s technical translations, marketing translations, or globalization consultancy, we know the life science industries, and how to help drive growth in global markets.
With years of experience in the industry providing accurate translations of user manuals, reference materials, clinical study protocols, marcom documentation, and much more we can help you produce regulatory submissions faster, more cost-efficiently, with high-quality and unprecedented scalability.
Learn more about our regulatory submission services.
At CSOFT, we advise, recommend, and consult with our clients to perform a risk analysis of each project before moving to production. While we use industry-standard processes, we also offer flexibility for each client, allowing for their companies’ success, no matter the process required.
Download our latest white paper on translation quality to find out why you should never assume all language service providers’ quality is equal.
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.
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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