TrialTrust – Global Clinical Trial Document Writing & Review Services for Moldova
Regulatory-Compliant | Authority-Ready | Globally Trusted
Clinical Trial Documentation Support for Moldova & International Submissions
TrialTrust, the scientific arm of Zoesoe Exports Pvt. Ltd., provides end-to-end Clinical Trial (CT) Document Writing, Review, and Regulatory Support Services for Moldova-based pharmaceutical and nutraceutical companies as well as organizations pursuing European and global market approvals.
We support local and export-oriented clinical programs, ensuring documentation that meets Medicines and Medical Devices Agency of Moldova (AMDM) expectations and aligns with European and international regulatory standards.
Since 2008, TrialTrust has successfully delivered 330+ clinical trial documentation projects for clients across Europe, Asia, Middle East, Africa, and LATAM.
Who We Are
TrialTrust is a specialized clinical and regulatory documentation partner supporting:
Moldova pharmaceutical manufacturers
Nutraceutical & dietary supplement companies
Export-focused product developers
CROs and regulatory consultants
We specialize in the writing, independent review, and post-submission query handling of:
Clinical Trial Protocols
Clinical Study Reports (CSR)
All documentation is supported by complete backup data, scientific justifications, and regulatory-aligned formats, ensuring inspection-ready and authority-acceptable submissions.
What We Do
We provide complete lifecycle support for Clinical Trial documentation — from protocol development through final submission and regulatory authority query closure.
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 & AMDM-ready formats
Alignment with ICH-GCP and EU regulatory expectations
📊 Clinical Study Report (CSR) Writing
Full ICH E3-compliant Clinical Study Reports
Clinical data interpretation & conclusions
Tables, Listings & Figures (TLFs)
Safety & efficacy evaluation
Investigator, site & subject data integration
Suitable for AMDM, EMA, and global submissions
📁 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 review of CT documents
Gap assessment against ICH-GCP, WHO, EMA, and local MOH requirements
Scientific consistency, traceability & data integrity checks
🛂 Post-Submission Query Handling
AMDM / EMA / Ethics Committee query responses
Scientific rebuttals & regulatory clarifications
Deficiency letter responses
Follow-up support until regulatory closure
Industries We Serve
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 prepared in alignment with:
ICH-GCP (E6)
ICH E3 – Clinical Study Reports
WHO Guidelines
EMA
USFDA
EU & CIS regulatory requirements
African & LATAM MOH requirements
Country-specific Ethics Committee formats
Why Choose TrialTrust
✅ 330+ Clinical Trial Documents Delivered Globally
✅ Dedicated Clinical & Regulatory Experts
✅ Pharma & Nutraceutical Specialization
✅ Authority-Acceptable & Inspection-Ready Documentation
✅ Strong Post-Submission Regulatory Support
✅ Confidential, Accurate & Timeline-Driven Execution
Our Experience Footprint
330+ products supported globally
Clients across Europe, Asia, Middle East, Africa & LATAM
Experience in new products, line extensions & lifecycle management
Support for local registrations and EU/global submissions
Our Working Approach
Requirement Understanding & Scope Finalization
Regulatory Strategy & Study Design Alignment
Clinical Document Preparation / Review
Internal Quality & Scientific Review
Client Review & Finalization
Post-Submission Authority Query Handling
Confidentiality & Quality Commitment
All projects are executed under strict confidentiality agreements, with robust quality control, version management, and data integrity practices, ensuring regulatory confidence and global acceptance.