TrialTrust Global Clinical Trial Document Writing & Review Services in Taiwan
Regulatory-Compliant | Authority-Ready | Globally Trusted
Who We Are
TrialTrust, the scientific arm of Zoesoe Exports Pvt. Ltd., provides end-to-end Clinical Trial (CT) Document Writing and Review Services for pharmaceutical and nutraceutical products across regulated and semi-regulated global markets.
Since 2008, we have successfully delivered 330+ clinical trial documentation projects for sponsors, CROs, and manufacturers across Taiwan, Asia-Pacific, Europe, the Middle East, Africa, and LATAM.
We specialize in the preparation, review, and post-submission support of Clinical Trial Protocols and Clinical Study Reports (CSRs), supported by robust scientific data, strong clinical justification, and regulatory-aligned documentation suitable for TFDA (Taiwan Food and Drug Administration) submissions and international filings.
Our Services for Clients in Taiwan
🧪 Clinical Trial Protocol Writing
Phase I–IV, BA/BE, Pilot & Pivotal studies
Pharmaceutical & Nutraceutical products
Study design, objectives, endpoints & statistical rationale
Inclusion/exclusion criteria & risk–benefit assessment
Ethics Committee & TFDA-ready formats
📊 Clinical Study Report (CSR) Writing
Full Clinical Study Reports compliant with ICH E3
Data interpretation & clinical conclusions
Tables, Listings & Figures (TLFs)
Safety & efficacy evaluation
Investigator and site data integration
📁 Backup & Supporting Documentation
Investigator’s Brochure (IB)
Informed Consent Forms (ICF)
Case Report Form (CRF) review support
Statistical Analysis Plan (SAP)
Literature review & clinical justification documents
🔄 Document Review & Gap Assessment
Independent technical & regulatory review of CT documents
Gap assessment against ICH-GCP, WHO, USFDA, EMA, TFDA & Asia-Pacific regulatory expectations
Scientific consistency & data integrity checks
🛂 Post-Submission Query Handling
Responses to TFDA & Ethics Committees
Scientific rebuttals & clarifications
Deficiency letter responses
Regulatory follow-up support until closure
Industries We Serve in Taiwan
Pharmaceutical Finished Dosage Forms
Biologics & Biosimilars
Nutraceuticals & Dietary Supplements
Herbal & Botanical Products
Functional Foods & Medical Nutrition
Export-oriented Clinical Development Programs
Taiwan & Asia-Pacific Regulatory Alignment
Our Clinical Trial documentation is prepared in alignment with:
ICH-GCP (E6)
ICH E3 – Clinical Study Reports
WHO Guidelines
TFDA (Taiwan Food and Drug Administration) regulations
USFDA & EMA reference standards
Country-specific Ethics Committee formats
Why Companies in Taiwan Choose TrialTrust
✅ 330+ Clinical Trial Documents Delivered Globally
✅ Experienced Asia-Pacific Clinical & Regulatory Experts
✅ Strong Pharma, Biologics & Nutraceutical Expertise
✅ Authority-Acceptable & Inspection-Ready Documentation
✅ End-to-End Post-Submission Support
✅ Confidential, Accurate & Timeline-Driven Execution
Our Experience Footprint
330+ products supported worldwide
Clients across Taiwan, Asia-Pacific, Europe & Middle East
Expertise in TFDA submissions, bridging studies & multinational development programs
Support for Taiwan-only, regional, and global regulatory filings
Our Working Approach
Requirement Understanding & Scope Finalization
Regulatory Strategy & Study Design Alignment
Clinical Document Preparation / Review
Internal Scientific & Quality Review
Client Review & Finalization
Post-Submission Authority Query Handling
Confidentiality & Quality Commitment
All projects are handled under strict confidentiality agreements, supported by strong quality management systems, version control, and data integrity practices, ensuring regulatory confidence and Asia-Pacific acceptance.
Contact TrialTrust in Taiwan
Looking for reliable, TFDA-aligned Clinical Trial documentation support for your pharmaceutical or nutraceutical product?
Partner with TrialTrust — where clinical science meets regulatory excellence.
📩 Contact us today to discuss your Clinical Trial documentation requirements in Taiwan.