CLINZTECH: Comprehensive Clinical & Non-Clinical Regulatory Solutions

CLINZTECH brings a deep understanding of global regulatory requirements, with demonstrated proficiency in ICH-GCP, FDA, EMA, and other international regulatory standards. Our multidisciplinary team includes highly qualified professionals in medicine, pharmacy, life sciences, and specialty medical fields—covering the full spectrum of therapeutic areas.

We offer end-to-end medical writing, regulatory submission support, and clinical trial monitoring services, with specialized capabilities in Japanese, German, and French.

Medical Writing Services

Clinical Medical Writing

We provide high-quality, scientifically accurate, and regulation-compliant documents that support every stage of the drug development lifecycle.

Key Deliverables:

• Study Synopses
• Protocols & Amendments (Phases I–IV)
• Investigator Brochures (IB)
• Informed Consent Forms (ICF)
• Clinical Study Reports (CSR)
• Abbreviated, Full, and Synoptic Reports
• Topline Summaries (TLS)
• Clinical Overviews (Module 2.5)
• Clinical Summaries (Module 2.7)
• Development Safety Update Reports (DSUR)
• Annual Safety Reports (ASR)
• Clinical sections of:
• New Drug Applications (NDAs)
• Investigational New Drug Applications (INDAs)
• Abbreviated New Drug Applications (ANDAs)
• New Drug Submissions (NDS)
• Abbreviated New Drug Submissions (ANDS)

Regulatory & Strategic Support:

• Gap analysis of clinical data in dossiers
• Clinical justification documents for global markets
• Pre-IND meeting support
• Labeling justification documents
• Response preparation for Health Authority (HA) queries
• Technical and expert review of regulatory dossiers
• Clinical study design and protocol authoring

Clinical Trial Monitoring & Audit Services

Our experienced monitors and auditors ensure that clinical trials meet ICH-GCP and local regulatory standards, supporting high-quality and ethical data generation.

Services Include:

• Phase I–IV trial monitoring
• Bioavailability (BA) and Bioequivalence (BE) study monitoring
• Bioanalytical monitoring
• Clinical and bioanalytical site audits
• CRO/vendor audits and system audits
• SOP development and compliance assessment

Non-Clinical Medical Writing Services

We support early drug development stages with robust and compliant documentation for preclinical research and toxicology assessments.

Deliverables:

• Nonclinical Overviews (Module 2.4)
• Nonclinical Summaries (Module 2.6)
• Pharmacology & Toxicology Written and Tabular Summaries
• Nonclinical Study Reports & Protocols
• Elemental Impurity Assessments
• Risk mitigation plans for Out-of-Specification (OOS) cases
• Toxicological Risk Assessments
• Occupational Exposure Limits (OEL) and Bands (OEBs)

Toxicological Evaluations:

• 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)
• Median Lethal Dose (LD50)
• Residual solvents and impurities in PPM

Multilingual Medical Writing Capabilities

To support global submissions and local regulatory compliance, our expert writers also offer full document preparation in:

• Japanese
• German
• French

This multilingual capability ensures that your documents are both scientifically sound and culturally tailored for target regions.

Why CLINZTECH?

• Domain expertise across all therapeutic areas
• Proven track record with regulatory agencies worldwide
• Multilingual, multi-format medical writing proficiency
• Rigorous quality assurance and peer review process
• Adaptability for sponsor-specific templates and regulatory frameworks