TrialTrust Global Clinical Trial Document Writing & Review Services in Maldives
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 South Asia, Asia-Pacific, the Middle East, Africa, Europe, 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 Maldives regulatory pathways and international submissions.
Our Services for Clients in Maldives
🧪 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 & authority-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, EMA, USFDA & Maldives MOH requirements
Scientific consistency & data integrity checks
🛂 Post-Submission Query Handling
Responses to Maldives Ministry of Health & Ethics Committees
Scientific rebuttals & clarifications
Deficiency letter responses
Regulatory follow-up support until closure
Industries We Serve in Maldives
Pharmaceutical Finished Dosage Forms
Generic & Branded Medicines
Nutraceuticals & Dietary Supplements
Herbal & Botanical Products
Functional Foods & Medical Nutrition
Export-oriented clinical programs
Maldives & Global Regulatory Alignment
Our Clinical Trial documentation is prepared in alignment with:
ICH-GCP (E6)
ICH E3 – Clinical Study Reports
WHO Guidelines
Maldives Ministry of Health regulations
USFDA & EMA reference standards
Country-specific Ethics Committee formats
Why Companies in Maldives Choose TrialTrust
✅ 330+ Clinical Trial Documents Delivered Globally
✅ Experienced South Asia & Global Clinical Experts
✅ Strong Pharma & Nutraceutical Specialization
✅ Authority-Acceptable & Inspection-Ready Documentation
✅ Comprehensive Post-Submission Support
✅ Confidential, Accurate & Timeline-Driven Execution
Our Experience Footprint
330+ products supported worldwide
Clients across South Asia, Asia-Pacific, Middle East & Europe
Experience in emerging regulatory markets and global filings
Support for local Maldives registrations and export submissions
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 global acceptance.
Contact TrialTrust in Maldives
Looking for reliable, authority-ready 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 Maldives.