TrialTrust Global
Clinical Trial Document Writing & Review Services – Nashik
CDSCO-Compliant | Ethics Committee–Ready | Globally Trusted
Trusted Clinical Trial Documentation Partner for Nashik
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 Nashik—one of India’s fastest-growing pharma manufacturing hubs.
We support local Indian regulatory submissions as well as global filings across Asia, Middle East, Africa, Europe, and LATAM.
Since 2008, TrialTrust has successfully delivered 330+ clinical trial documentation projects, helping Indian manufacturers achieve authority acceptance, inspection readiness, and timely approvals.
Who We Serve in Nashik
We work with:
Pharmaceutical manufacturing units in Nashik & MIDC areas
Nutraceutical & dietary supplement manufacturers
Herbal & botanical product companies
Generic & branded pharma companies
Export-oriented manufacturers targeting regulated markets
Whether your clinical trial is India-based or conducted overseas, we ensure documentation aligns with Indian regulations and global expectations.
Our Clinical Trial Documentation Services
🧪 Clinical Trial Protocol Writing
Regulatory-ready Clinical Trial Protocols aligned with Indian and international guidelines:
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
Comprehensive ICH E3-compliant Clinical Study Reports:
Full CSR writing & medical interpretation
Safety & efficacy evaluation
Tables, Listings & Figures (TLFs)
Investigator & site data integration
Clear clinical conclusions for regulatory submission
📁 Backup & Supporting Documentation
Complete support documents required for Indian submissions and global 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:
CDSCO / SEC / Ethics Committee query responses
Scientific rebuttals & clarification documents
Deficiency letter responses
Regulatory follow-up until approval or closure
Industries We Support in Nashik
Pharmaceutical Finished Dosage Forms
Nutraceuticals & Dietary Supplements
Herbal & Botanical Products
Functional Foods & Medical Nutrition
Generic & Branded Products
Export-driven clinical development programs
Regulatory Alignment & Compliance
All 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 Nashik Companies Choose TrialTrust
✅ 330+ Clinical Trial Documents Delivered
✅ Strong Experience Supporting Indian Pharma Hubs
✅ Specialized in Pharma & 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 new products, 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 Nashik projects are handled under strict confidentiality agreements, supported by:
Robust quality control systems
Version control & audit readiness
Scientific accuracy & data integrity assurance
Delivering regulatory confidence and global acceptance.
Get in Touch – Nashik Clinical Trial Support
Looking for CDSCO-ready, globally accepted Clinical Trial documentation for your pharma or nutraceutical product in Nashik?
Partner with TrialTrust — where clinical science meets regulatory excellence.
📩 Contact us today to discuss your Clinical Trial documentation needs.