Pacific Bridge Medical
Pacific Bridge Medical has been helping healthcare companies in Asia for over 37 years, specializing in regulatory and business development services for drug, medical device, biotech, IVD, and other healthcare companies. They assist clients in navigating Asian markets, with a focus on regulatory compliance, market entry, and strategic growth in countries like Japan, China, Korea, Taiwan, and others. The company also provides expertise in clinical trials, product registration, reimbursement strategies, and post-market surveillance, supporting the development and commercialization of healthcare products across Asia. They offer comprehensive regulatory services, including guidance on submission documents, post-market surveillance requirements, and compliance with local standards such as GMP, GCP, and ISO 13485. The company also provides resources like webcasts, charts, publications, and research reports to support clients' market entry and regulatory strategies.
Industries
Nr. of Employees
small (1-50)
Pacific Bridge Medical
Bethesda, Maryland, United States, North America
Services
Country-specific regulatory planning and execution for pharmaceuticals, medical devices and IVDs in Asian jurisdictions; includes dossier preparation, electronic filing, product classification and authority liaison.
Preparation, translation and submission support for Drug Master Files and Device Master Files to national authorities, including technical sections, stability data and letters of authorization.
Audit preparation and response services, CAPA development, QMS documentation support and remediation planning for GMP and QMS inspections across Asian regulators.
Technical preparation of e-dossiers to meet national portal specifications (format, metadata, PDF/XML), localized translations and file organization aligned to agency guidelines.
Preparation of reimbursement dossiers, health-economic models and evidence packages to support pricing and listing decisions under regional payor systems, including Japan NHI interactions.
Identification, due diligence, contracting and performance management of distribution partners, with assessment of regulatory, reimbursement and logistical capabilities.
Country-specific regulatory planning and execution for pharmaceuticals, medical devices and IVDs in Asian jurisdictions; includes dossier preparation, electronic filing, product classification and authority liaison.
Preparation, translation and submission support for Drug Master Files and Device Master Files to national authorities, including technical sections, stability data and letters of authorization.
Audit preparation and response services, CAPA development, QMS documentation support and remediation planning for GMP and QMS inspections across Asian regulators.
Technical preparation of e-dossiers to meet national portal specifications (format, metadata, PDF/XML), localized translations and file organization aligned to agency guidelines.
Preparation of reimbursement dossiers, health-economic models and evidence packages to support pricing and listing decisions under regional payor systems, including Japan NHI interactions.
Identification, due diligence, contracting and performance management of distribution partners, with assessment of regulatory, reimbursement and logistical capabilities.
Expertise Areas
- Regulatory compliance and country-specific submissions across Asia
- Medical device, IVD and SaMD classification and registration
- Drug Master File (DMF) preparation and management for China and other Asian markets
- Market access, reimbursement and HTA submissions (including Japan NHI/Chuikyo pathways)
Key Technologies
- Common Technical Document (CTD) and regional dossier formats
- Electronic submission formats and portals (PDF, XML, national e-submission systems)
- Good Manufacturing Practice (GMP) frameworks (including KGMP, TGMP)
- Good Clinical Practice (GCP) standards and clinical registry use
News & Updates
An article discussing the increasing neurological disorders in Asia and opportunities for Western neurology companies.
An article about the rapid expansion of radiology and radiotherapy markets in China due to healthcare reforms.
An article on the evolving drug reimbursement policies in China and their impact on market access.
An overview of Japan’s pharmaceutical market and regulatory environment.
Details on Thailand’s expanding pharmaceutical sector and regulatory framework.
Updates on Singapore’s medical device regulation and registration processes.
An article discussing the increasing neurological disorders in Asia and opportunities for Western neurology companies.
An article about the rapid expansion of radiology and radiotherapy markets in China due to healthcare reforms.
An article on the evolving drug reimbursement policies in China and their impact on market access.
An overview of Japan’s pharmaceutical market and regulatory environment.
Details on Thailand’s expanding pharmaceutical sector and regulatory framework.
Updates on Singapore’s medical device regulation and registration processes.