TrialTrust – Global Clinical Trial Document Writing & Review Services for Mumbai
Regulatory-Compliant | Authority-Ready | Globally Trusted
Clinical Trial Documentation Support for Mumbai & India
TrialTrust, the scientific arm of Zoesoe Exports Pvt. Ltd., provides end-to-end Clinical Trial (CT) Document Writing, Review, and Regulatory Support Services for Mumbai-based pharmaceutical, nutraceutical, and healthcare companies, as well as organizations pursuing national and global market approvals.
We support local submissions to the Indian Central Drugs Standard Control Organization (CDSCO) and ethics committees across Maharashtra and India, ensuring documentation aligned with Indian regulations and harmonized with international clinical research standards.
Since 2008, TrialTrust has successfully delivered 330+ clinical trial documentation projects for clients across India, Asia, LATAM, North America, Europe, Middle East, and Africa.
Who We Are
TrialTrust is a specialized clinical and regulatory documentation partner supporting:
Pharmaceutical manufacturers and importers in Mumbai
Nutraceutical & dietary supplement companies
Herbal, botanical & functional food product developers
CROs and research institutions
We specialize in the preparation, independent review, and post-submission query handling of:
Clinical Trial Protocols
Clinical Study Reports (CSR)
All documentation is supported by complete backup data, strong scientific justification, and CDSCO-aligned formats, ensuring inspection-ready and regulator-acceptable submissions.
What We Do
We provide complete lifecycle support for Clinical Trial documentation — from protocol development and Ethics Committee submission to final report 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 & CDSCO-ready formats
Alignment with ICH-GCP and Indian 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 CDSCO, ICMR, FDA, 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, CDSCO, ICMR, WHO, FDA, and EMA requirements
Scientific consistency, traceability & data integrity checks
🛂 Post-Submission Query Handling
CDSCO / 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
CDSCO / ICMR Guidelines
WHO Guidelines
USFDA
EMA
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 India, Asia, LATAM, North America, Europe, Middle East & Africa
Experience in new products, line extensions & lifecycle management
Support for local registrations and international 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 handled under strict confidentiality agreements, supported by robust quality control systems, version control, and data integrity practices, ensuring regulatory confidence and global acceptance.
Get in Touch
Looking for reliable, CDSCO-compliant Clinical Trial documentation support for your pharmaceutical or nutraceutical product in Mumbai, Maharashtra?
Partner with TrialTrust — where clinical science meets regulatory excellence.
📩 Contact us today to discuss your Clinical Trial documentation needs.