TrialTrust – Global Clinical Trial Document Writing & Review Services
For Pharmaceutical & Nutraceutical Companies in Mauritius
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 Mauritius for local regulatory submissions and international market approvals.
Since 2008, TrialTrust has successfully delivered 330+ clinical trial documentation projects across Asia, Middle East, Africa, Europe, and LATAM, ensuring scientific rigor, regulatory compliance, and authority acceptance.
We specialize in the preparation, independent review, and post-submission query handling of Clinical Trial Protocols and Clinical Study Reports, supported by complete backup data, strong scientific justifications, and regulator-aligned documentation.
What We Do
We provide complete lifecycle support for Clinical Trial documentation—from protocol development to final report submission and post-submission authority / ethics committee query resolution—tailored for sponsors, manufacturers, MAHs, and exporters operating in or from Mauritius.
Our Core Clinical Trial Services
🧪 Clinical Trial Protocol Writing
Clinical Trial Protocols (Phase I–IV, BA/BE, Pilot & Pivotal studies)
Protocols for Pharmaceutical & Nutraceutical products
Study design, objectives, endpoints & statistical rationale
Inclusion / exclusion criteria & risk–benefit assessment
Ethics Committee–ready & regulator-aligned formats suitable for Mauritius and importing markets
📊 Clinical Study Report (CSR) Writing
Full ICH E3–compliant Clinical Study Reports
Clinical data interpretation & scientific conclusions
Tables, Listings & Figures (TLFs)
Safety & efficacy evaluation
Investigator, site & multicenter data integration
📁 Backup & Supporting Documentation
Investigator’s Brochure (IB)
Informed Consent Forms (ICF)
Case Report Form (CRF) review support
Statistical Analysis Plan (SAP)
Literature reviews & clinical justification documents
🔄 Document Review & Gap Assessment
Independent technical & regulatory reviews of CT documents
Gap assessment against ICH-GCP, WHO, US FDA, EMA & local MOH expectations
Scientific consistency, traceability & data integrity checks
🛂 Post-Submission Query Handling
MOH / Ethics Committee / FDA / EMA query responses
Scientific rebuttals & clarifications
Deficiency letter responses
Regulatory follow-up support until approval or closure
Industries We Serve in Mauritius
Pharmaceutical Finished Dosage Forms
Nutraceuticals & Dietary Supplements
Herbal & Botanical Products
Functional Foods & Medical Nutrition
Generic & Branded Products
Export-oriented & multi-country 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
GCC
African & LATAM MOH requirements
Country- and ethics committee–specific formats (Mauritius & importing markets)
Why Mauritius-Based Clients 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 query handling expertise
✅ 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 Mauritius local registrations 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, supported by robust quality systems, version control, and data integrity practices, ensuring regulatory confidence and global acceptance.