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Regulatory Compliance Solutions

Complete global submissions
Clear regulatory hurdles
Shorten development timelines

Global Regulatory Solutions

Our clients that operate in highly regulated industries know all too well the immense effort required to achieve and stay current with regulatory compliance requirements. To complicate matters, it seems that with every passing quarter the regulatory and accompanying compliance burden increases. Offering service and technology focusing on addressing compliance issues in the global marketplace is a key differentiator for Translations.com.

For clients that manufacture medical and in-vitro diagnostic devices obtaining the CE Mark designation means the door to the large and potentially lucrative EU market can be opened. However, obtaining the CE Mark is not without translation challenges. Our solutions help a wide range of clients comply with all relevant EU directives. Further, we help our clients stay abreast of the latest movement in the shifting rules of compliance.

Clients that deal in the arena of financial services have never before faced an environment with more onerous regulatory requirements than the ones they face today. Across the board, our global financial clients are faced with new initiatives, including the Dodd–Frank Wall Street Reform and Consumer Protection Act, Basel III Accord for banking clients, to its sister initiative, Solvency II, for insurance companies. Further, in addition to these requirements specific to given sectors, our broader base of clients must now comply with Sarbanes-Oxley, The Patriot Act, and IAS (International Accounting Standards).

Whether you're a European-based multinational that trades on a US exchange and is facing Sarbanes-Oxley for the first time, or an in-vitro diagnostic device manufacturer seeking a labeling strategy that complies with EU regulations, as a world-leading translation company, Translations.com can help.

While there is no magic compass to navigate the immense translation requirements brought on by the current onslaught of regulation, there are ways to lessen the pain. Translations.com will work with you to establish a translation process that can make multilingual compliance issues as painless as possible.

Regulatory Consulting Services

  • Global Submissions
  • Multilingual Packaging
  • Regulatory Consulting
  • eCTD Support
  • Labeling Translation
  • Labeling Alignment
  • Medical Writing
  • CTA Prep & Review