Lionbridge Showcases Global Regulatory Solutions for Life Sciences Organisations at RAPS 2017 Regulatory Convergence Event

Lionbridge’s Integrated Global Regulatory Solutions Simplify, Accelerate and Support Organisations’ Multinational Compliance.

NATIONAL HARBOR, Md. – September 11, 2017 – Lionbridge Technologies, Inc., the world’s most trusted translation and digital communications company, will exhibit its Global Regulatory Solutions for Life Sciences this week at the 2017 Regulatory Convergence Event, presented by the Regulatory Affairs Professionals Society (RAPS). Lionbridge’s regulatory solutions help life sciences organisations meet ever-changing global regulatory requirements through a variety of specialised services ranging from translation to label creation to independent review.

As pharmaceutical and medical device companies expand distribution of medicines and products around the globe, maintaining timelines is critical to avoiding delays or upholding the scheduled release cycle. However, managing global regulatory documentation presents many challenges. Around the world, diverse regions have their own medical advisory bodies or underwriters, and many organisations struggle to adhere to these diverse compliance requirements—particularly when working against strict timelines.

“Local regulatory authorities are taking a more active role in how pharma and medical device products come to market in their regions, and many organisations are struggling to execute multilingual, transnational campaigns,” said Mark Aiello, General Manager, Lionbridge Life Sciences. “It can be complex to centralise processes and manage cultural adaptation and translation in a regulated environment. Lionbridge’s Global Regulatory Solutions for Life Sciences empower organisations with the management, tools and expertise they need to complete on-time, high-quality submissions to local regulatory bodies, and ultimately accelerate time to market.”

Lionbridge’s life sciences regulatory solutions adhere to validated certifications and rigorous methodologies to deliver high-quality regulatory translation services and strategy in one integrated solution, while focusing on fast turnaround times to help organisations comply with the ever-changing, ever-challenging global regulatory environment. Key benefits include:

  • Simplified, on-demand project management: Lionbridge’s dedicated project managers are available 24/7 worldwide to support complex multinational, multilingual regulatory submission deadlines for any given medical or pharma release. Because project managers can administer seamlessly across regions and teams, organisations are able to simplify processes, meet deadlines and manage deliverables across geographies and departments.
  • Specialised teams of global regulatory professionals: Lionbridge works with a network of qualified medical subject matter experts, reviewers, translators, writers and proofreaders with years of direct experience working with local health authorities around the world. This team is proficient in all Health Advisory and regulatory bodies, from the FDA in the U.S. and the European Medicines Agency (EMA) to SFDA Approval and Registration for Medical Devices in China and more. This expertise allows organisations to confidently manage regulatory compliance globally.
  • Robust portfolio of multilingual regulatory compliance services: This portfolio of services includes translation and formatting resources to ensure submissions will be routed through a seamless regulatory approval process.
  • Globally recognised certification and validation program: Lionbridge has developed and implements a globally recognised certification and validation program that is recognised and praised by local health authorities to ensure organisations receive best-in-class resources.
  • Flexible managed service offer: Organisations can also take advantage of technology as a managed service. This easy-to-implement, flexible solution offers linguistic asset management, streamlined in-country language review processes and other content management solutions and authoring tools to simplify and streamline processes across regions and teams.

Lionbridge’s robust Global Regulatory Solutions portfolio also includes the company’s recently enhanced Clinical Labeling translation solution, an end-to-end offering that helps global life sciences organisations easily translate labeling content for clinical studies, while remaining compliant with global regulatory requirements.

Attendees at the 2017 Regulatory Convergence Event can view a demo of the Global Regulatory Solutions for Life Sciences onsite at the Lionbridge booth #405.

To learn more about Lionbridge’s proven, rigorous process to support multilingual regulatory and compliance needs, visit https://www.lionbridge.com/en-gb/life-sciences/global-regulatory-solutions.

About Lionbridge

Lionbridge enables more than 800 world-leading brands to increase international market share, speed adoption of products and effectively engage their customers in local markets worldwide. Using our innovative cloud technology platforms and our global crowd of more than 100,000 professional cloud workers, we provide detail-critical business processes, including translation, online marketing, global content management and application testing solutions that ensure global brand consistency, local relevancy and technical usability across all touch points of the customer lifecycle. Based in Waltham, Mass., Lionbridge maintains solution centres in 27 countries. To learn more, visit www.lionbridge.com.

Media Contact:

Aimee Jen
Text100
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