Regulatory Affairs Services Provider in Taiwan
Taiwan is a strategically important life sciences market in the Asia-Pacific region, known for its robust regulatory oversight and strong alignment with international quality standards. However, successful life sciences product registration in Taiwan requires a clear understanding of TFDA-specific regulatory pathways, documentation standards, and local compliance expectations.
At DDReg, we provide specialized Regulatory Affairs Services in Taiwan, supporting global and local pharmaceutical, biotechnology, and medical device companies with market entry, product registration, and full lifecycle regulatory compliance. With hands-on experience across TFDA submissions, DDReg acts as a trusted Regulatory Affairs Consultant in Taiwan, delivering structured, regulator-ready solutions.
Understanding the Regulatory Affairs Process in Taiwan
Regulatory oversight in Taiwan is governed by the Taiwan Food and Drug Administration (TFDA), operating under the Ministry of Health and Welfare (MOHW). TFDA is responsible for:
- Approval of pharmaceutical products, biologics, and medical devices
- Regulation of clinical trials and investigational products
- Product classification and registration pathways
- Oversight of GMP, GCP, and GDP compliance
- Post-market surveillance and safety monitoring
As an experienced TFDA Regulatory Consultant, DDReg supports clients throughout the regulatory affairs process in Taiwan, ensuring submissions align with current TFDA expectations and evolving guidance.
Our Regulatory Expertise in Taiwan
DDReg offers end-to-end regulatory consulting services in Taiwan, customized to support both multinational and regional companies. Our approach combines local regulatory intelligence with global regulatory best practices, enabling efficient approvals and sustainable compliance. We work closely with TFDA requirements to reduce approval timelines, minimize regulatory queries, and support long-term market presence.
Our Regulatory Affairs Consulting Services in Taiwan
- Regulatory strategy and Taiwan market entry pathway assessment
- Product classification and TFDA compliance mapping
- Pre-submission regulatory planning and readiness assessments
- Preparation, publishing, and submission of dossiers (CTD and TFDA formats)
- TFDA RA approval services for pharmaceuticals and biologics
- Life sciences product registration in Taiwan
- Medical Device Registration in Taiwan across all risk classes
- Technical documentation and Essential Principles compliance support
- Labeling, IFU, and packaging review (Traditional Chinese requirements)
- Authorized local agent and in-country regulatory representation
- Coordination and regulatory liaison with TFDA
- Gap analysis and regulatory remediation planning
- Lifecycle management, including renewals, variations, and post-approval changes
- Regulatory query handling and deficiency response management
- Post-market regulatory compliance and change control
- Ongoing local regulatory intelligence and policy monitoring
As a dedicated Taiwan Regulatory Consulting Firm, DDReg delivers consistent, authority-aligned regulatory execution.
Why Choose DDReg as Your Regulatory Affairs Consultant in Taiwan?
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TFDA-Focused Regulatory Expertise
Our consultants possess deep knowledge of TFDA procedures, review practices, and documentation standards. -
Local Execution with Global Regulatory Perspective
We support Taiwan-specific submissions while maintaining alignment with ICH and global regulatory frameworks. -
Strategic Partner for Market Access
DDReg is more than a regulatory service provider; we support long-term compliance, lifecycle management, and regulatory risk mitigation in Taiwan.
Industries We Support in Taiwan
- Pharmaceutical and Generic Drug Manufacturers
- Biotechnology and Life Sciences Companies
- Medical Device and Diagnostics Manufacturers
- Combination Products and Advanced Therapies
- Companies entering or expanding in the Taiwan market
Our Regulatory Affairs Consulting Services in Taiwan portfolio covers:
Regulatory Strategies
The pharmaceutical industry operates under stringent regulations to ensure the safety, efficacy, and quality...
New Product Marketing Authorizations
Navigating marketing authorization is a complex and time-sensitive process. Every country has its own regulatory framework...
Gap Analysis and Remediation
In the highly regulated pharmaceutical industry, maintaining compliance is critical. Regulatory gap analysis helps identify deficiencies in technical documentation...
Regulatory Due Diligence
Regulatory issues arise unexpectedly and can create significant strain on a company’s resources. As such, it is advisable for all companies to carry out regular and frequent regulatory due diligence and audits...
API & DMF services
Drug Master Files (DMFs) contain confidential and detailed information regarding API processes—from manufacturing to storage. DDReg’s DMF Services deliver precise...
CMC Advisory
DDReg’s CMC services are dedicated to assisting customers in developing robust and an efficient regulatory strategy through all development phases - authoring...
Post Approval Life Cycle Management
Maximize product value with expert pharma lifecycle management. Our dedicated team ensures that your product remains on shelves and compliant with ever-evolving regulations through strategic post-approval management...
Certification Services
Partner with DDReg to navigate the complex process of regulatory certification of pharmaceutical...
ANDA and MA Holder Services
Our comprehensive services support both Abbreviated New Drug Applications (ANDA) and Marketing Authorization processes.
Publishing & Submission
Our comprehensive digital solution transforms traditional paper dossier submissions into a streamlined electronic format. With robust infrastructure and cutting‐edge management processes...
