TrialTrust Global
Clinical Trial Document Writing & Review Services – Thane
CDSCO-Compliant | Ethics Committee–Ready | Globally Trusted
Trusted Clinical Trial Documentation Partner for Thane
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 companies in Thane and the Mumbai Metropolitan Region (MMR).
Thane is a major hub for API manufacturing, formulations, contract manufacturing, and exports, and TrialTrust supports companies seeking Indian regulatory approvals and international market access across Asia, Middle East, Africa, Europe, and LATAM.
Since 2008, TrialTrust has successfully delivered 330+ clinical trial documentation projects, helping sponsors achieve regulatory acceptance, inspection readiness, and timely approvals.
Who We Serve in Thane & MMR
We work with:
Pharmaceutical & API manufacturers in Thane
Formulation & contract manufacturing organizations (CMOs)
Nutraceutical & dietary supplement manufacturers
Herbal & botanical product companies
Generic & branded pharma organizations
Export-oriented manufacturers targeting regulated markets
Whether your clinical trial is India-based or multinational, we ensure documentation meets CDSCO, Ethics Committee, and global regulatory expectations.
Our Clinical Trial Documentation Services
🧪 Clinical Trial Protocol Writing
Regulatory-ready Clinical Trial Protocols aligned with Indian and international standards:
Phase I–IV Clinical Trial Protocols
BA/BE, Pilot & Pivotal study protocols
Pharma & Nutraceutical product protocols
Study design, objectives, endpoints & statistical rationale
Inclusion/exclusion criteria & risk–benefit assessment
Ethics Committee & CDSCO-aligned formats
📊 Clinical Study Report (CSR) Writing
Complete ICH E3-compliant Clinical Study Reports for Indian and global submissions:
End-to-end CSR writing & medical interpretation
Safety & efficacy evaluation
Tables, Listings & Figures (TLFs)
Investigator & site data integration
Clear clinical conclusions for regulatory submission
📁 Backup & Supporting Documentation
Comprehensive documentation support required for approvals and exports:
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 scientific and regulatory review services:
Gap assessment against:
ICH-GCP (E6)
New Drugs & Clinical Trials Rules (NDCTR), India
CDSCO / SEC expectations
WHO, USFDA & EMA guidelines
Scientific consistency & data integrity checks
🛂 Post-Submission Query Handling
End-to-end regulatory follow-up support until closure:
CDSCO / SEC / Ethics Committee query responses
Scientific rebuttals & clarification documents
Deficiency letter responses
Ongoing regulatory follow-up support
Industries We Support in Thane
Pharmaceutical Finished Dosage Forms
Active Pharmaceutical Ingredients (APIs)
Nutraceuticals & Dietary Supplements
Herbal & Botanical Products
Functional Foods & Medical Nutrition
Generic & Branded Products
Export-driven clinical development programs
Regulatory Alignment & Compliance
All clinical trial documents are prepared in alignment with:
CDSCO (India)
NDCTR, 2019
ICH-GCP (E6)
ICH E3 – Clinical Study Reports
WHO Guidelines
USFDA
EMA
ASEAN, GCC, African & LATAM MOH requirements
Ethics Committee-specific formats
Why Thane Companies Choose TrialTrust
✅ 330+ Clinical Trial Documents Delivered
✅ Strong Experience Supporting MMR Pharma & API Clusters
✅ Expertise in Pharma, API & Nutraceutical Products
✅ Authority-Acceptable & Inspection-Ready Documentation
✅ Reliable Post-Submission Regulatory Support
✅ Confidential, Accurate & Timeline-Driven Execution
Our Experience Footprint
330+ products supported globally
Clients across India, Asia, Middle East, Africa, Europe & LATAM
Experience in APIs, formulations, line extensions & lifecycle management
Support for Indian registrations and global exports
Our Working Approach
Requirement Understanding & Scope Finalization
CDSCO & Global Regulatory Strategy Alignment
Clinical Document Writing / Review
Internal Quality & Scientific Review
Client Review & Finalization
Post-Submission Authority Query Handling
Confidentiality & Quality Commitment
All Thane projects are handled under strict confidentiality agreements, supported by:
Robust quality control systems
Version control & audit readiness
Scientific accuracy & data integrity assurance
Ensuring regulatory confidence and global acceptance.
Get in Touch – Thane Clinical Trial Support
Looking for CDSCO-ready, globally accepted Clinical Trial documentation for your pharma or nutraceutical product in Thane or the Mumbai Metropolitan Region?
Partner with TrialTrust — where clinical science meets regulatory excellence.
📩 Contact us today to discuss your Clinical Trial documentation needs.