Expert Regulatory Translations for Fast Submissions
We help you get global regulatory approvals faster with flawless language translation for regulatory affairs that meet strict conditions. Our linguists are well-versed with regulatory terminology and processes that ensure your documents are translated accurately and fully compliant with the guidelines of health authorities in different regions. Whether it’s an EMA submission or getting away with the challenges of NMPA and PMDA criteria, we help your product gain market access quickly and seamlessly.
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Our clients
World’s top organizations rely on CCJK
Premium Translations for All Regulatory Bodies
Our certified regulatory translation services address the needs of major regulatory authorities, including the EMA, NMPA, and PMDA. We help you streamline your medical approval process and enter global markets seamlessly.
Regulatory Translation Services for EMA
The European Medicines Agency (EMA) is a significant regulatory organization responsible for the examination, supervision, and safety monitoring of medicines in the European Union. Our translation services will comply with EMA’s specifications to ensure compliant medical regulatory documents translation.
Regulatory Submission Translation for NMPA
The NMPA (National Medical Products Administration) is China’s regulatory body that oversees pharmaceuticals, medical devices, and healthcare products. It applies demanding guidelines to verify product safety and efficacy. We provide regulatory materials translation tailored to NMPA’s unique terminology that guarantees accuracy in product registration, clinical reports, and labeling.
Regulatory Translation for PMDA
The Pharmaceuticals and Medical Devices Agency (PMDA) is Japan’s regulatory authority that governs medications, healthcare devices, and biotech solutions. Our compliance translation services ensure your submissions resonate with Japan’s language and formatting standards.
Regulatory Translations for Smooth FDA Submissions
The FDA submission process poses unique challenges, including stringent documentation requirements, adherence to regulatory frameworks, and a high degree of technical precision. Our regulatory affairs translation services eliminate potential roadblocks by ensuring that critical sections are translated with absolute accuracy and technical alignment. Additionally, FDA submissions require strict conformity to guidelines on drug labeling, adverse event reporting, and patient information, all of which we manage through precise translation practices.
Secure & Confidential Translations For Your Critical Documents
We employ strict confidentiality policies and data protection practices so that your critical data remains secure throughout the translation process. From clinical study reports to regulatory dossiers translations, our service is designed to maintain the highest level of trust that will give you peace of mind as you meet regulatory deadlines.
- Drug Registration Dossiers
- Drug Product Information
- Informed Consent Forms (ICFs)
- Medical Device Manuals
- Patient Information Leaflets
- Clinical Study Reports
- Marketing Authorization Applications (MAAs)
- Standard Operating Procedures (SOPs)
Let’s Discuss Your Regulatory Compliance Translation Needs!
Complaint Labeling for Medical Devices and Pharmaceuticals
Our regulatory translation services address the intricate technical challenges associated with labeling so that every element, from user instructions to packaging labels, is meticulously translated to achieve rigorous local regulatory standards for each market. CCJK’s translations guarantee global compliance and enhance user understanding that ultimately supports the safe delivery of healthcare solutions worldwide.
Why Choose CCJK As Your Regulatory Translation Agency
It’s crucial to choose the right translation partner for your regulatory submissions translations to achieve successful global submissions. Here’s why CCJK is the trusted regulatory translation company for the world’s leading organizations.
100% Human Translations
Your regulatory translation projects are handled by expert human translators, with zero reliance on automated tools. This human touch guarantees the highest quality and gives you confidence in your submissions.
Accuracy Guaranteed
We follow a meticulous quality assurance process to ensure your submissions are error-free, compliant, and ready for approval, minimizing risks and accelerating your time to market. With us, you are saved from rejections or compliance issues.
Dedicated Project Managers
At CCJK, your professional compliance translation projects are monitored and handled by professional PMs to ensure they abide by quality standards and deliver the final outcomes on time. Clients can coordinate with PMs to get updates on their translations.
Tailored Solutions
We offer tailored translation solutions based on your industry, target market, and specific regulatory body. From new drug application to multilingual labeling, you get exactly what you need for successful global submissions.
Stay Ahead of Regulatory Challenges
Meet Your Regulatory Translation Experts
Dr. Emily Carter
Dr. Emily Carter is an English to Spanish medical translator. She specializes in regulatory submissions for clinical trials, ensuring that documents meet the stringent requirements of FDA and EMA.
Maria Rodriguez
Maria is a seasoned pharmaceutical translator with experience of 7+ years in Latin American regulations. She has expertise in clinical trials and regulatory submissions.
Anna Schneider
With a Master’s in Public Health, Anna Schneider is adept in German translation of regulatory guidelines and documentation for pharmaceuticals. Her 6 years of experience in the field ensures precise communication of complex medical terminology to support compliance.
Laura Martinez
Laura Martinez has over 9 years of experience in translating clinical research documents for medical trials. She has a strong grip on English, French and Portuguese. Her understanding of regulatory requirements helps clients navigate the complexities of submissions to global health authorities.
Ravi Kumar
Ravi Kumar has 8 years experience in translating medical device regulatory documents in Hindi and Tamil. With a background in regulatory affairs, he expertly handles technical files, risk assessments, and labeling to ensure compliance with global standards.
Elena Rossi
Fluent in English, Italian, and Spanish, Elena has dedicated her career to translating regulatory documents in the medical sector. With a background in clinical research and trial, she excels at conveying intricate jargon with clarity, ensuring accuracy and adherence to local regulations.
Clients’ Testimonials
Their translators are experts in the regulatory field, ensuring our submissions are compliant and well-prepared.
Regulatory Affairs DirectorWe've been partnering with CCJK for years, and their regulatory translation services have consistently exceeded our expectations. They efficiently translate complex regulatory texts while preserving the original intent and meaning.
Regulatory Affairs ConsultantCCJK has been an invaluable asset in ensuring our global regulatory compliance. Their expertise has significantly reduced our time-to-market for our medical devices, and mitigated regulatory risks. Highly recommended.
CEO of a Medical Device CompanyCCJK team of regulatory translators has proven to be a valuable asset. Their expertise has helped us meet regulatory deadlines and ensure our products are compliant with international standards.
Founder of a Pharmaceutical CompanyCCJK's medical regulatory translations are accurate, timely, and culturally sensitive. They always meet our high standards.
Regulatory Affairs ManagerFAQs
frequently asked questions
What payment options do you accept?
We accept multiple payment methods to accommodate our clients’ preferences for an effortless transaction process. Clients can pay via major credit and debit cards, including Visa and MasterCard. For large scope projects, we offer the option of bank transfers. If anyone requires a customized payment plan, our team will arrange the most suitable option for them.
What measures do you take to maintain my documents’ security?
At CCJK, we follow stringent security protocols to protect our clients’ medical information throughout translation process. All our translators have signed a non-disclosure agreement (NDAs) so that your documents remain confidential. We also use secure file transfer methods and encrypted storage to protect any data from unauthorized access.
Could you also help with proofreading or editing of translated documents?
Yes, our linguists review your documents to eliminate any logical and grammatical mistakes or language inconsistencies. If you require expert editing for your translated documents, we have experienced resources to help you improve your documents’ fluency. Our proofreading services are designed to refine your content, making sure it is accurate and effectively communicates your message to the target audience.
Is desktop publishing or formatting also included in your services?
Yes, we ensure that your translated documents maintain the original layout and formatting. Our DTP specialists can work with various file formats and design software that allows them to accurately recreate the visual appearance of your documents in any language. Whether it’s brochures, manuals, or ad content, we modify the text to fit the layouts and ensure proper placement of graphics.
Are your translation services certified?
Yes, CCJK is an ISO-approved regulatory translation agency, providing certified translations that are accepted by legal authorities, government organizations, and academic institutions.