Optimizing global compliance
Regulatory compliance,
at scale
at scale
Solutions to reach and maintain global regulatory compliance
Benefits Simplify global compliance
All-in-one
Document translation workflows built for compliance with all regulatory requirements
Speed & reliability
Regulatory submission workflows built to absorb tight deadline constraints, every time
Local expertise
Our team have done it all, everywhere, so you can rely on our regulatory expertise globally
Our solution Global regulatory submission and compliance, simplified
Because we understand the intricate regulatory landscape our industry evolves in, we created solutions to facilitate its management on the global scale.With our in-depth knowledge and meticulous attention to detail, we help organizations navigate complex regulatory frameworks across different markets, and accurately translate and adapt critical documents, such as clinical trial protocols, regulatory submissions, and labeling requirements.
Our comprehensive language services for global regulatory compliance
- Regulatory document translation: Accurate translation of essential regulatory documents, such as clinical trial protocols, investigator brochures, patient information leaflets, and adverse event reports.
- Labeling and packaging translation: Localization of product labels, packaging materials, instructions for use, and patient safety information to meet country-specific regulatory requirements.
- Regulatory submission support: Assistance in translating and preparing regulatory submissions, including INDs, NDAs, DMFs, and CTD dossiers, ensuring compliance with regional guidelines and requirements.
- Compliance with Medical Device Regulations (MDR): Translation and adaptation of medical device documentation, including IFUs, labeling, and technical specifications, to comply with global medical device regulations, such as MDR and IVDR.
- Pharmacovigilance translations: Accurate translation of pharmacovigilance documents, such as adverse event reports, safety data sheets, and risk management plans, to ensure patient safety and compliance with global pharmacovigilance regulations.
- Regulatory advisory and consulting: Expert guidance and consulting services to navigate complex regulatory frameworks, assess language-related compliance risks, and develop strategies for successful global market entry.
Insights The EUCTR: when translations become strategic
In the ever-evolving landscape of clinical trials, compliance with regulatory frameworks is paramount.With the introduction of the new EU Clinical Trials Regulation (EUCTR), translations play a crucial role in ensuring compliance and facilitating effective communication throughout the trial process.
The EUCTR mandates that all documents related to clinical trials, including informed consent forms, protocols, and patient information leaflets, be translated into the language of each participating country. This new regulation also mandates much shorter submission deadlines, bringing down timelines from months to weeks, creating additional complexity.
Accurate translations not only ensure compliance with EUCTR requirements but also enable participants to fully understand the trial procedures, potential risks, and benefits.
Additionally, translated materials foster inclusivity and help build trust among diverse patient populations, ultimately contributing to the success and ethical conduct of clinical trials in the European Union.
An industry expert language service provider can help sponsors and researchers navigate this complex regulatory landscape.
