Medical Writing Service

CLINZTECH has comprehensive understanding of various regulatory guidelines such as ICH-GCP, FDA, EMA guidelines. Our team consisting of persons with qualifications in medical, pharmaceutical and other life science subjects, speciality doctors who have expertise across all the therapeutic areas.

We also provide medical writing services in Japanese, German and French languages.

Skilled Areas:

• Synopses
• Protocols and amendments
• Investigators Brochure
• Informed Consent Forms(ICFs)
• Clinical Study Reports
• Clinical Summaries
• Study Reference Manual
• CTD modules
• Annual and periodic Safety Reports
• Non-clinical Study Reports, Summaries and Overviews

Clinical Medical Writing Services:

Regulatory Writing Services

1. Preparation and review of
   • Clinical overviews (eCTD Module 2.5)
   • Clinical summaries (eCTD Module 2.7)
   • Clinical study reports (eCTD Module 5)
   • Topline Summary (TLS) for clinical study reports
   • Clinical justification documents for EU, US and other emerging markets
   • Investigator Brochure (IB)
   • Informed Consent Form (ICF)
   • Clinical sections of New Drug Applications (NDAs), Investigational New Drug Applications (INDAs), Abbreviated New Drug Applications (ANDAs), New Drug Submissions (NDS) and Abbreviated New Drug Submissions (ANDS)
2. Gap analysis for dossiers in clinical part
3. Clinical and nonclinical document support
4. Handling queries during HA meetings and responding to HA
5. Technical review of dossiers
6. Clinical study design
7. Preparation of Development Safety Update Report (DSUR)
8. Preparation of Annual Safety Reports (ASR)

Clinical Trail Monitoring Services

• Protocol writing and expert review of phase I, phase II, phase III & phase IV clinical studies including protocol amendments
• Regulatory CSR writing and review compliant with ICH GCP guidelines including CSR body and shell, synoptic, abbreviated and full submission reports
• Preparation and review of Topline Summary (TLS) for CSR
• Investigator Brochure (IB) development and expert review
• Informed Consent Form (ICF) preparation and expert review
• Preparation of IND application supporting documents
• Clinical sections of New Drug Applications (NDAs), Investigational New Drug Applications (INDAs), Abbreviated New Drug Applications (ANDAs), New Drug Submissions (NDS) and Abbreviated New Drug Submissions (ANDS)
• Regulatory dossier writing services
• Preparation and review of clinical overview (module 2.5) and clinical summary/summaries (module 2.7)
• Pre-IND meeting support
• Regulatory support for compilation and review of pre-submission package
• Preparation of labeling justification document

Clinical Trail Audit and Monitoring Services

• Clinical monitoring of phase I trial and bioequivalence studies
• Bio-analytical monitoring of phase I trial and bioequivalence studies
• Auditing of CRO/study site
• System audits of phase I-BE CRO/study site
• Bioequivalence (BE) study services
• Bioavailability (BA) study services
• Preparation and review of Clinical SOP

Non-Clinical Medical Writing Services:

Pre-clinical Development and Safety Services:

1. Preparation and review of
   • Pharmacological Written and Pharmacological Tabular Summaries
   • Toxicological Written and Toxicological Tabular Summaries
   • Nonclinical Overview (Module 2.4)
   • Nonclinical Summary/Summaries (Module 2.6)
   • Nonclinical Study Report
   • Nonclinical Protocol
2. Elemental Impurity Assessment Services
3. Toxicological Risk Assessment and Review of risk mitigation plan for Out of Specification (OOS)
4. Occupational Exposure Limit (OEL)
5. Occupational Exposure Bands (OEBs)
6. Determination of
   • no-observed-adverse-effect level (NOAEL)
   • no observed effect level (NOEL)
   • lowest-observed-adverse-effect-level (LOAEL)
   • Permitted Daily Exposure (PDE)
   • Accepted Daily Exposure (ADE)
   • Threshold of Toxicological Concern (TTC)
   • the median lethal dose (LD50)
   • residual solvents and impurities in PPM