CoreStrengths

Positioning: We reject the "general translator" model and build high-caliber teams with both "medical expertise + language proficiency." Among more than 6,000 certified experts across over 200 countries worldwide, 85% hold life sciences-related qualifications, including MDs, master’s degree holders in pharmacy, and former regulatory reviewers. More than 1,500 translators focus on highly specialized fields such as oncology drugs, minimally invasive surgical devices, and gene therapy.

ApexMemory Corpus: Stores more than 30 million entries of medical corpora, including package inserts, Medical Devices technical documents, and clinical trial reports, enabling real-time retrieval of expressions from similar projects;

Key-Term Terminology System: Features built-in "life sciences termbases" recognized by the FDA, EMA, and NMPA, including terminology related to mRNA vaccines and in vitro diagnostic reagents, ensuring terminology consistency across documents;

Multi-lanORC: Accurately identifies technical parameters in Medical Devices drawings and dosage units on drug labels, helping avoid layout recognition errors.

Positioning: We reject one-size-fits-all solutions and tailor our services according to client type—pharmaceutical companies, device

manufacturers, and research institutions—and specific scenarios such as new drug registration, overseas facility setup, and SCI publishing: Multinational Pharmaceutical Companies: We provide integrated services combining "global multi-center Clinical Trials document translation + country-specific regulatory submission adaptation," including differentiated language adjustments for the FDA, EMA, and PMDA;

Research Institutions: We customize dedicated workflows for "interpretation for international collaborative meetings + translation of joint research reports."

Innovative Biotechnology Companies: We design combined solutions covering "patent translation + scientific paper editing + financing document Localization";

Positioning:

We cover not only more than 60 language pairs, but also the high-frequency languages most critical to the life sciences sector:

Scientific Publishing Languages: English for top international journals, German for European research publications, and Japanese for East Asian academic exchange.

Emerging Market Languages: Hindi (CDSCO, India), Thai (Thai FDA), and Indonesian (BPOM, Indonesia), supporting the expansion of Medical Devices into Southeast Asia;

Core Regulatory Languages: English (FDA/EMA), German (BfArM, Germany), Japanese (PMDA), Korean (MFDS), and French (ANSM, France), ensuring submission document compliance;

Quality System: We strictly follow three major certifications—ISO 17100 for translation quality, ISO 9001 for full-process management, and ISO 13485 for Medical Devices—to ensure documents meet medical industry standards;

Review Process: Every life sciences document undergoes four levels of control: "initial translation by the translator + expert revision + regulatory compliance review + final project review";

Information Security: Clinical Trials data and patient privacy information are stored in encrypted form in accordance with ISO 27001, HIPAA, and GDPR requirements.

信息安全：按 ISO 27001 及 HIPAA（美国医疗隐私法）、GDPR（欧盟数据保护）要求，加密存储临床试验数据、患者隐私信息。

Positioning: We understand that "time is value" in the life sciences sector—new drug registrations have fixed deadlines, and Clinical Trials often need to be launched in parallel. To support this, we have established:

24/7 Emergency Response Teams: Providing rapid support for "urgent IND submission documents" and "unexpected international medical conference interpretation";

Tiered Delivery Mechanism: Multi-center Clinical Trials documents can be delivered in phases—"ethics review draft → statistical analysis draft → final submission draft"—to ensure no key milestone is delayed.

Positioning: Our core team consists of four types of specialists in the life sciences sector:

Industry Language Experts: Focused on specialized areas such as medicine, pharmacy, and device engineering, with an average of more than 10 years of translation experience;

Localization Engineers: Proficient in the localization of Medical Devices software interfaces and electronic drug labels;

Regulatory Consultants: Familiar with the submission processes and language requirements of the FDA, EMA, and NMPA;

Scientific Research Support Specialists: Skilled in SCI paper editing, especially for top-tier journals such as Nature-branded journals and The Lancet.

Positioning: We build dedicated databases for long-term life sciences clients:

Exclusive Termbases: Capturing product-specific terminology to ensure unified expression across global documents;

Historical Corpora: Storing clients' previous Clinical Trials reports and package inserts to avoid repetitive translation while maintaining style consistency;

Compliance Databases: Continuously aligning with the regulatory language requirements of clients' target markets, such as the FDA’s latest guidance on package insert formatting.

Positioning: We provide full-chain language services for the life sciences sector, covering the entire process from "R&D - Registration - Manufacturing - Market - Research":

Translation: Clinical Trials protocols, package inserts, patent documents, and scientific papers;

Interpretation: Simultaneous interpretation for international medical conferences, communication among multinational R&D teams, and overseas factory training;

Localization: Medical Devices software interfaces, electronic drug labels, and patient training videos (voice-over + subtitles);

Value-Added Services: Regulatory compliance consulting, such as interpretation of EMA language requirements, as well as SCI paper publishing support.

Positioning: We do more than just "guarantee translation quality"—we also take responsibility for "compliance outcomes" in the life sciences sector:

Quality Standards: Translations must meet the language requirements of the target country’s regulatory authorities, such as the FDA and NMPA, ensuring that no compliance-related revisions are required;

Lifetime Commitment: If translation issues result in regulatory deficiency notices or scientific paper rejection, we provide free revisions until all requirements are met;

Quality Traceability: We retain complete records of the entire "translation - review - delivery" process for every document, supporting traceability review by regulatory authorities.

Positioning: Our dedicated DTP team is highly experienced in the specialized formatting requirements of life sciences documents and uses tools such as CorelDRAW and Adobe InDesign:

Pharmaceutical Documents: Strictly adhering to FDA and EMA requirements for fonts, line spacing, and warning placement in drug labels and package inserts;

Medical Devices Documentation: Ensuring precise alignment between technical drawings, operating procedure diagrams, and text, in line with CE-related formatting requirements;

Scientific Papers: Adapting to the formatting templates of top-tier journals such as Nature and Cell, avoiding formatting issues that could affect peer review.

Positioning: In the highly sensitive and highly regulated life sciences sector, we earn our clients’ long-term trust through two core strengths:

Compliance Credibility: We have served more than 50 global life sciences leaders, including MSD, Bayer, and Mindray, and completed more than 1,000 FDA, EMA, and NMPA submission document translations with zero major compliance incidents;

Security Credibility: We strictly comply with data protection regulations such as HIPAA and GDPR, maintain a 100% confidentiality record for clients’ Clinical Trials data and patent information, and have been recognized as a benchmark for information security in the life sciences sector for 10 consecutive years.