Global leading language service provider
EN
CN EN

Integrated Compliance Services from Market Authorization Applications to Lifecycle Risk Management

End-to-End Compliance Solutions for Drugs and Medical Devices, Powered by eCTD, Terminology Resources, and Expert Teams.

Request a Market Authorization Assessment Learn About Post-Market Evaluation Services

  • Key Pain Points：Common Challenges Faced by Enterprises

    Market application documents fail to cover regulatory concerns, leading to review delays or requests for supplementary information;

    Insufficient capabilities in post-market safety signal detection and response, affecting compliance and brand reputation;

    Varying post-market requirements across multiple markets (periodic reports, variation submissions), resulting in high maintenance costs;

    Lack of systematic post-market studies (PMS/PMCF/PASS/RWE), making it difficult to support regulatory or business decisions;

    Labels (package inserts) and risk management (RMP/PV) fail to be updated in a timely manner with new evidence.

    VS

    Solution：Our Approach

    We provide end-to-end services from submission preparation → approval coordination → post-market monitoring and evaluation → continuous variation management. Our focus is on early risk identification, streamlined responses, and reusable knowledge assets (termbases, templates, eCTD architecture), helping clients manage the product lifecycle in a controllable and compliant manner.

End-to-End Workflow Example (Combining Linear and Iterative Approaches)

  • 01
    RighInfo002521-ico_3.png

    Initial Assessment

    Confirmation of project scope, target markets, timelines, and regulatory pathways.

  • 02
    RighInfo002521-icon1.png

    Gap Analysis

    Identifying gaps between existing materials and target market requirements.

  • 03
    RighInfo002521-ico_3.png

    Strategy Development

    Comprehensive planning and timelines for submissions, post-market studies, and risk management.

  • 04
    RighInfo002521-icon2.png

    Document Preparation

    Technical writing, linguistic validation, and terminology consistency checks (utilizing termbases).

  • 05
    Floor002530-icon1.png

    Technical Construction

    eCTD dossier building, XML generation, DTP publishing, formatting, and validation.

  • 06
    RighInfo002521-ico_3.png

    Submission and Review Coordination

    Document submission, preparation for regulatory Q&A, and review response support.

  • 07
    RighInfo002521-icon1.png

    Post-Market Monitoring

    Signal detection, periodic report writing, RMP updates, and risk communication.

  • 08
    RighInfo002521-ico_3.png

    Variation and Maintenance

    Variation submissions, supplementary material processing, and long-term document management.

Quality Control Hierarchy

  • 01
    RighInfo002521-ico_3.png

    Regulatory compliance checks (reviewed by regulatory experts)

  • 02
    RighInfo002521-icon1.png

    Content consistency (cross-module consistency validation)

  • 03
    RighInfo002521-ico_3.png

    Data and statistical verification (RWE, PASS reports)

  • 04
    RighInfo002521-icon2.png

    Formatting and technical validation (eCTD/XML/DTP/document integrity)

  • Customizable SOPs and compliance templates: Shortening delivery cycles and improving the efficiency of review coordination.
  • Combining technical platforms with regulatory expertise to control technical risks while providing regulatory strategy support;
    
Dedicated to linking "data and text" to create explainable and traceable regulatory materials;;
    
Supporting long-term projects and parallel management across multiple markets, reducing overall compliance maintenance costs.
  • Supports modular submissions, version management, and traceable lifecycle control, facilitating variation management and historical traceability.
  • Ensuring terminology and expression consistency across multilingual submission dossiers and post-market documents.
  • Collaborative participation of experts in medical writing, regulatory affairs, epidemiology, statistics, PV/Vigilance, and clinical research.
  • Combining RWE and statistical analysis to support more precise risk monitoring and decision-making.

Post-Market Risk Management and Label Updates for New Indications
Background

A marketed drug collected new safety signals after expanding its indications.

Solution

Conducted signal evaluation, designed targeted PASS, updated the RMP and draft package insert, and supported the submission of variation documents to regulatory authorities.

Results

Completed risk assessment and communication document submissions, assisting the client in clarifying risk mitigation pathways and communication strategies.

Medical Device PMCF and Post-Market Surveillance Compliance Support
Background

A medical device required PMCF completion after its EU launch to maintain the compliance evidence chain.

Solution

Designed the PMCF plan, implemented registry enrollment, conducted data analysis, and wrote the final PMCF report (including localization and DTP).

Results

The PMCF report met compliance requirements, supporting continuous market access and clinical evidence reinforcement.

Consistency Update Project for Overseas Marketed Drug Package Inserts
Background

Due to regulatory requirements, an originator drug needed simultaneous updates to its package inserts and safety information across multiple countries and regions.

Solution

Conducted regulatory gap analysis on core safety information, developed a global label consistency update strategy, and completed multilingual label revisions, compliance reviews, and submission support.

Results

Label updates were completed simultaneously across multiple markets, reducing compliance risks caused by information inconsistencies and enhancing the uniformity of global product management.

Global Consultation Hotline：400 680 7218
21st Floor, Building 19, Zhonghai Xin Innovation Industry City, Jihua Street, Longgang District, Shenzhen
Copyright © 2025 甲骨文翻译（深圳）有限公司 All Rights Reserved.ICP
Legal NoticeFriendshipLinkSitemap