Ensuring the success of marketing authorization applications (MAAs) and clinical trials as well as related regulatory submissions is one of the most critical goals for pharmaceutical companies—and there are reasons why. Being able to introduce new or improved drugs into global markets does not just impact a company’s business performance and market reach, it also provides patients with access to pharmaceutical products that can significantly improve their well-being and the successful treatment of illnesses.

Our knowledge of global pharmaceutical markets and experience with regulatory submissions help global pharmaceutical companies meet these goals. We achieve this by providing translation solutions that focus on the unique needs and challenges of pharmaceutical companies. Whether it involves regional MAA processes, clinical trials, or simply supporting faster and more cost-effective practices for submitting critical documentation to meet clinical needs and regulatory requirements, we can provide the necessary flexibility and capacity to accommodate your specific situation.

Highlights

We offer solutions that meet the needs of pharmaceutical companies:

• Work within tight timelines with predefined submission milestones

• Specialized subject matter and process expertise to ensure translation quality

• Simultaneous management of translations across multiple regions and the client’s country offices

• Linguistic validation of patient reported outcome (PRO) instruments involving unique languages and rare diseases

• Support of studies with many languages (>60) and rare diseases

• Adherence to unique terminology requirements (e.g., EN source, QRD templates, MedDRA, EDQM Standard Terms, etc.)

• Strict submission rules and format requirements

• Fast translation turnaround times (from 8 hours to 5 days)

• Real-time (24/7) process visibility, including project status and quality reporting through our AURORA platform

• Automated documentation routing and feedback collection

• Effective, timely communication between multiple stakeholders

• Compliance with Harmonization-Good Clinical Practice (ICH-GCP) guidelines to ensure the quality of clinical trial data

Content and Document Types

We utilize dedicated and prequalified linguists who are both subject matter experts and have a working knowledge of the underlying processes as well as information format requirements.

In addition to these fundamental needs, we support pharmaceutical companies across a broad range of documentation to meet the needs of different pharmaceutical groups within your organization. Our extensive experience translating and preparing diverse documentation includes, but is not limited to the following document types (in alphabetical order):

• Case report forms

• Clinical trials protocols

• Clinician reported outcomes (CROs)

• General product labels

• Informed consent forms

• Patient diaries

• Patient information leaflets (PILs)

• Patient reported outcomes (PROs), including ePROs

• Pharmacovigilance/adverse events

• Protocols/study plans

• Research articles

• Scales and quality-of-life (QoL) instruments

• Study reports

• Summary of product characteristics (SmPCs)

Whether your company pursues markets in Europe, North America, Latin America, or Asia/Asia Pacific, we can support your MAA and clinical trials as well as regulatory submissions through customized and timely translation services. Our approach distinguishes itself by accommodating your company’s specific situation without compromising expected quality and your individual experience with our service delivery. We achieve this through a dedicated and scalable team structure supported by ourAURORA platform.

To learn more about our approach and services, please contact us.