TrialTrust – Global Clinical Trial Document Writing & Review Services
For Pharmaceutical & Nutraceutical Companies in Bhutan
Regulatory-Compliant | Authority-Ready | Globally Trusted
Who We Are
TrialTrust, a scientific arm of Zoesoe Exports Pvt. Ltd., provides end-to-end Clinical Trial (CT) Document Writing and Review Services for pharmaceutical and nutraceutical products, supporting organizations in Bhutan for local approvals and international submissions.
Since 2008, we have successfully delivered 330+ clinical trial documentation projects across Asia, Middle East, Africa, Europe, and LATAM, ensuring regulatory alignment, scientific accuracy, and authority acceptance.
What We Do
We offer complete lifecycle support for Clinical Trial documentation—from protocol development to final report submission and post-submission authority responses—tailored for sponsors, manufacturers, and exporters operating in or from Bhutan.
Our Core Clinical Trial Services
🧪 Clinical Trial Protocol Writing
Clinical Trial Protocols (Phase I–IV, BA/BE, Pilot & Pivotal studies)
Protocols for Pharma & Nutraceutical products
Study design, objectives, endpoints & statistical rationale
Inclusion/exclusion criteria & risk–benefit assessment
Ethics Committee–ready & regulator-aligned formats suitable for Bhutan and importing markets
📊 Clinical Study Report (CSR) Writing
ICH E3–compliant Clinical Study Reports
Clinical data interpretation & 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 reviews
Gap assessment vs ICH-GCP, WHO, US FDA, EMA & local MOH expectations
Scientific consistency, traceability & data integrity checks
🛂 Post-Submission Query Handling
MOH / FDA / Ethics Committee responses
Scientific rebuttals & clarifications
Deficiency letter handling
Regulatory follow-up support until closure
Industries We Serve in Bhutan
Pharmaceutical Finished Dosage Forms
Nutraceuticals & Dietary Supplements
Herbal & Botanical Products
Functional Foods & Medical Nutrition
Generic & Branded Products
Export-oriented Clinical Programs
Global Regulatory Alignment
Our Clinical Trial documentation is aligned with:
ICH-GCP (E6)
ICH E3 – Clinical Study Reports
WHO Guidelines
US FDA
EMA
ASEAN
GCC
African & LATAM MOH requirements
Country-specific Ethics Committee formats (Bhutan & importing countries)
Why Choose TrialTrust
✅ 330+ Clinical Trial Documents Delivered Globally
✅ Dedicated Clinical, Statistical & Regulatory Experts
✅ Strong Pharma & Nutraceutical specialization
✅ Authority-acceptable & inspection-ready documentation
✅ Proven post-submission support
✅ Confidential, accurate & timeline-driven execution
Our Experience Footprint
330+ products supported worldwide
Clients across Asia, Middle East, Africa, Europe & LATAM
Experience in new products, line extensions & lifecycle management
Support for local registrations in Bhutan and global submissions
Our Working Approach
Requirement understanding & scope finalization
Regulatory strategy & study design alignment
Clinical document preparation / independent review
Internal quality & scientific review
Client review & finalization
Post-submission authority & ethics committee query handling
Confidentiality & Quality Commitment
All projects are handled under strict confidentiality agreements, with robust quality systems, version control, and data integrity practices, ensuring regulatory confidence and global acceptance.