甲骨文翻译（深圳）有限公司

Global leading language service provider

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Full-Process Support Services for Pharmaceutical R&D
Providing One-Stop Language and Compliance Support from R&D Design to Registration and Launch

Integrating translation, localization, eCTD publishing, DTP, multimedia, interpreting and translation, and termbase management to provide traceable, compliant, and reusable deliverables for every stage of drug and medical device R&D.

Consult R&D Support Now Download Service List (PDF)

Common Issues：Real Pain Points for R&D Teams

Multi-department and multi-vendor collaboration leads to text inconsistencies and chaotic versioning;

Clinical/CMC/non-clinical documents cannot be directly used for registration submissions due to formatting and terminology issues;

Terminology becomes fragmented during parallel multilingual advancement, causing comprehension deviations at the review and user ends;

eCTD/technical formatting errors or XML validation failures lead to rejections or delays;

Multimedia content for training, presentations, and academic communication lacks professional adaptation and production.

VS

Solution：Our Approach

Glyph Translation (Shenzhen) Co., Ltd. provides systematic, auditable full-process support

Ensuring structure and lifecycle management with our proprietary eCTD platform;

Ensuring multi-project consistency with centralized termbases and TMs;

Achieving a closed loop from "translation to usable finished products" with professional DTP and multimedia teams;

Involving language experts with regulatory/clinical/CMC backgrounds to participate in compliance proofreading throughout the process.

End-to-End Workflow

01

Project Initiation

Requirement gathering, document inventory, and compliance/timeline assessment
02

Resource Allocation

Matching translators, reviewers, DTP, QA, and SMEs (Subject Matter Experts)
03

Terminology Preparation

Term extraction, termbase synchronization, and TM initialization
04

Initial Translation and Technical Proofreading

Translation → Professional review (SME) → Terminology consistency check
05

DTP/eCTD Construction

Layout processing → XML generation → System validation (Proprietary Software)
06

Submission and Maintenance

Assistance with official submission → Subsequent supplementary material and version management
07

Pre-Submission Validation

Comprehensive check of content/structure/format/hyperlinks/bookmarks/cross-references

Quality Control Hierarchy

01

Linguistic quality

language pairs, grammar, terminology
02

Professional consistency

SME review
03

Technical integrity

DTP, XML, formatting
04

Compliance validation

official tools and proprietary validation

Automated XML generation, built-in rule validation, and version and lifecycle management, reducing human errors and increasing the first-time pass rate.

Supporting multi-project and multilingual consistency, reducing repetitive work and review costs.

Integrated production from source files to compliant submission drafts and training videos, reducing formatting rework.

Deep involvement of language experts and project managers with medical, regulatory, clinical, and CMC backgrounds.

Every decision and modification can be recorded and traced

Supporting global markets and parallel multilingual delivery

Platforms and workflows support integration with enterprise-specific compliance rules and SOPs

Reducing subsequent rework and review cycles through technology and knowledge assets.

Target Clients: Pharmaceutical companies, CROs, medical device, and biotechnology companies (long-te
Collaboration Capabilities: Supporting registration types such as IND, NDA, ANDA, DMF, and MAA
Security and Compliance: Strict Non-Disclosure Agreements (NDA), data access control, and compliance
Professional Team: Project managers and SMEs with regulatory backgrounds, supported by long-term tra

Cross-Regional IND Submission Support

Background

A biopharmaceutical company was preparing to conduct parallel IND submissions in multiple countries, with chaotic document languages and historical versions.

Solution

Termbase organization → Restructuring module structures using the proprietary eCTD platform → Multilingual translation and DTP → Pre-submission validation.

Results

The first-round pass rate significantly improved, and the processing time for subsequent supplementary materials was shortened by 40%.

Medical Device Global Launch Preparation

Background

A single device required simultaneous submission of registration dossiers and preparation of user training packages in the EU and Southeast Asian markets.

Solution

Parallel localization and DTP → Multilingual multimedia training video production → Termbase support and long-term maintenance.

Results

Launch timelines were synchronized across multiple markets, training materials were put directly into use, and after-sales complaints decreased significantly.

Generic Drug International Registration R&D Dossier Integration Project

Background

A pharmaceutical company planned to expand into overseas markets, but R&D, manufacturing, and registration dossiers were scattered across multiple departments, making historical data organization highly difficult.

Solution

Assisted in organizing R&D stage data and CMC documents → Unified the CTD module structure → Provided multilingual translation, eCTD publishing, and pre-submission technical validation support.

Results

The logic of the registration dossiers became clearer and more complete, cross-departmental collaboration efficiency improved, and the international registration preparation cycle was significantly shortened.

Entrust R&D Language Management to a Compliance-Conscious Team

Tell us your R&D stage, target markets, and main document types——we will provide an actionable solution ranging from termbase development to eCTD submission, and from DTP to multimedia training.

Apply for a Free R&D Compliance Assessment Upload materials for feasibility assessment