TrialTrust Global
Clinical Trial Document Writing & Review Services – Pune
CDSCO-Compliant | Ethics Committee–Ready | Globally Trusted
Trusted Clinical Trial Documentation Partner for Pune
TrialTrust, a scientific arm of Zoesoe Exports Pvt. Ltd., provides end-to-end Clinical Trial (CT) Document Writing and Review Services for pharmaceutical, biotechnology, nutraceutical, and CRO organizations in Pune—one of India’s leading life sciences and clinical research hubs.
We support 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, ensuring authority acceptance, inspection readiness, and timely approvals.
Who We Serve in Pune
We work with:
Pharmaceutical & biotechnology companies
Clinical Research Organizations (CROs)
Nutraceutical & dietary supplement manufacturers
Herbal & botanical product companies
Generic & branded pharma organizations
Export-oriented life sciences companies
Whether your clinical trial is India-based, multi-center, or global, we ensure documentation meets Indian and international regulatory expectations.
Our Clinical Trial Documentation Services
🧪 Clinical Trial Protocol Writing
Regulatory-ready Clinical Trial Protocols aligned with Indian and global standards:
Phase I–IV Clinical Trial Protocols
BA/BE, Pilot & Pivotal study protocols
Pharma, Biotech & 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:
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
Complete support documentation 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:
CDSCO / SEC / Ethics Committee query responses
Scientific rebuttals & clarification documents
Deficiency letter responses
Regulatory follow-up until approval or closure
Industries We Support in Pune
Pharmaceutical Finished Dosage Forms
Biotechnology & Biosimilars
Nutraceuticals & Dietary Supplements
Herbal & Botanical Products
Functional Foods & Medical Nutrition
Generic & Branded Products
CRO-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 Pune Companies Choose TrialTrust
✅ 330+ Clinical Trial Documents Delivered
✅ Strong Experience Supporting Pharma, Biotech & CRO Ecosystems
✅ Specialized in Pharma, Biotech & 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, biosimilars, line extensions & lifecycle management
Support for Indian registrations and global submissions
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 Pune 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 – Pune Clinical Trial Support
Looking for CDSCO-ready, globally accepted Clinical Trial documentation for your pharma, biotech, or nutraceutical product in Pune?
Partner with TrialTrust — where clinical science meets regulatory excellence.
📩 Contact us today to discuss your Clinical Trial documentation needs.