Enhancing Regulatory Success: Language Solutions for Clinical Trials and FDA Submissions
In the Life Sciences industry, accurate and effective communication is everything. At Akorbi, we know the challenges that come with navigating FDA compliance. That's why our language services are tailor-made for the life sciences industry. Our experts provide precise translation and localization of crucial documents, alongside seamless interpretation solutions, to facilitate successful FDA meetings and collaborations. We support your regulatory compliance efforts with our comprehensive multilingual content management services. With our in-depth understanding of FDA guidelines, let us help you bring your products to market.
Translation Services for Clinical Trials and FDA Compliance
Our team of expert linguists and subject matter experts specialize in creating precise and accurate translations of crucial clinical trial documents. As the life sciences industry navigates the stringent FDA guidelines and requirements, our team offers a reliable solution for translating informed consent forms, investigator brochures, and other regulatory submissions.
Localization Services to Reach Global Markets
Akorbi's localization services go beyond mere translation to help you expand your products globally. We help you tailor your clinical trial materials to specific markets while also ensuring compliance with local regulations and cultural norms. Our team of experts work hard to make sure product information, documentation, and labels resonate with different audiences all across the world. This gives you the confidence you need to navigate new markets efficiently and quickly, so you can attain market approval sooner.
Interpretation Solutions for FDA Meetings and Collaborations
Collaborating with the FDA is vital for clinical trial progress and gaining regulatory approval. Akorbi offers expert interpretation solutions to ensure smooth communication during these crucial interactions. Our skilled interpreters accurately convey complicated scientific and regulatory information, ensuring everyone involved understands all the details. By eliminating language barriers, we help you present your research, answer regulatory inquiries, and navigate FDA procedures with confidence.
Multilingual Content Management for Regulatory Compliance
We provide multilingual content management solutions that meet rigorous FDA submission requirements. Our team of language specialists, project managers, and tech experts work with you to create efficient processes and ensure consistency across languages. We assist with everything from terminology databases to translation workflows, helping you meet deadlines and maintain linguistic excellence in your regulatory documents. With Akorbi by your side, you can confidently navigate the complexities of clinical trials and FDA compliance, accelerating your path to market success.
Akorbi Recognition
We strive to provide our clients with the highest-quality language services and game-changing technology, and we’re proud to share that our efforts have been recognized time and again.
ISO 13485:2016
Certification: ISO 13485:2016
Certification body: SRI
About ISO 13485: ISO 13485:2016 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements.
ISO 9001:2015
Certification: ISO 9001:2015
Certification body: SRI
About ISO 9001: ISO 9001:2015 specifies requirements for a quality management system.
ISO 27001:2013
Certification: ISO 27001:2013
Certification body: SRI Quality System Registrar
About ISO 27001: ISO 27001 is the international standard for information security management system for continuing conformance to information security requirements. To know more about this standard, click Learn More below.
Dallas 100
For 30 years, the Caruth Institute for Entrepreneurship at the SMU Cox School of Business and the Dallas 100TM sponsors have celebrated the innovative spirit, determination and business savvy of area entrepreneurs. We have saluted the diversity, creativity and resolve it takes to create and sustain a successful business in today’s competitive environment.
Learn More
Minority Business Enterprise
Certification: MWBE Minority Business Enterprise
Certification body: State of Tennessee
Objective: Certified to perform business at the state of Tennessee level as a Minority Business Enterprise.
Proud Sponsors of Translators Without Borders
Translators without Borders is a nonprofit working toward a world without language barriers.
Learn More
CSA Research
Common Sense Advisory (CSA) Top 30 NA Language Service Providers Rankings:
- 2020
- Global: 29
- North America: 11
Nimdzi Insights
Nimdzi is a market research and international consulting company that works towards
providing clients with the insights needed to succeed on a global scale.
- 2018
- Global: 24
- North America: 12
- 2019
- Global: 36
- North America: 11
- 2020
- Global: 35
- North America: 12
Women Owned
Certification: Women-Owned Enterprise
Certification body: North Central Texas Regional Certification Agency
Objective: Certified to perform business at the local government level as a MWBE.
Slator LSP Index
The Slator 2020 Language Service Provider Index is a ranking and index of the world’s largest language service providers, translation agencies, localization providers, interpreting services providers, and language technology companies.
- 2018
- Global: 28
- North America: 13
- 2019
- Global: 27
- North America: 9
- 2020
- Global: 26
- North America: 10
50 Fastest Women-Owned / Led
Certification: Women-Owned Enterprise
Certification body: Women’s Business Enterprise National Council – Southwest
Objective: Certified to conduct business as a woman-owned business.
ISO 17100:2015
Certification: ISO 17100:2015
Certification body: SRI Quality System Registrar
About ISO 17100: ISO 17100 is the international standard for information security management system for continuing conformance to information security requirements. To know more about this standard, click Learn More below.
ISO 27701:2019
Certification: ISO 27701:2019
Certification body: SRI Quality System Registrar
About ISO 27701: ISO 27701 is the international standard for information security management system for continuing conformance to information security requirements. To know more about this standard, click Learn More below.
We Speak Over 170 Languages
Akorbi ensures that cultural differences never hinder communication. Our dedicated team is ready to facilitate your global interactions with unmatched precision. Connect with us today and let's navigate the world of languages together.
Streamline your Language Processes with Low-Code
We go beyond traditional language services by offering an advanced low-code platform that automates and integrates workflows, providing significant benefits to the life sciences industry. Imagine streamlining the translation and review cycles of critical clinical trial documents, ensuring accurate and timely submissions. Our platform seamlessly integrates with existing systems, such as clinical trial management and electronic document management systems, allowing for effortless data exchange and real-time updates. This automation and integration result in enhanced productivity, reduced turnaround times, and improved quality assurance, all vital for success in the fast-paced world of life sciences.
