Non-Clinical Content Authoring - Techsol Life Sciences

Content Authoring Services

Non- Clinical Content Authoring

Overview

At Techsol Life Sciences, we specialize in developing regulatory-compliant non-clinical overviews, summaries, and study reports, offering end-to-end support for authoring, compilation, and submission of high-quality, submission-ready documentation. Leveraging our in-depth knowledge of global health authority requirements and evolving international regulatory expectations, including ICH guidelines, we ensure seamless preparation of non-clinical content that enables sponsors to confidently navigate complex regulatory landscapes and achieve successful submissions.

Techsol Expertise in Non-Clinical Regulatory Content Authoring

Techsol has extensive experience in developing non-clinical documentation that is pivotal for demonstrating the safety and supporting the risk assessment of pharmaceuticals, biologics, and Advanced Therapy Medicinal Products (ATMPs), including complex cell and gene therapies.

For INDs (Investigational New Drug Applications), the non-clinical package supports first-in-human (FIH) studies by demonstrating that the therapy is reasonably safe to proceed.
For NDAs (New Drug Applications) and BLAs (Biologics License Applications), non-clinical content substantiates the comprehensive safety profile and supports labeling claims.
Gene Therapy and ATMP Submissions require specialized non-clinical assessments focusing on biodistribution, shedding, immunogenicity, tumorigenicity, insertional mutagenesis, and long-term follow-up (LTFU) per FDA Guidance (2023) and EMA CAT requirements.

Non-Clinical CTD Report Structure

Non-clinical reports are structured according to ICH M4S (Safety) and eCTD Module 4, which typically includes:

1. Non-Clinical Overview (Module 2.4)

Executive summary of pharmacology, pharmacokinetics (PK), and toxicology
Integrated risk assessment highlighting safety margins and clinical translation relevance

2. Non-Clinical Written and Tabulated Summaries (Module 2.6)

Pharmacology Summary (Primary, Secondary, and Safety Pharmacology)
Pharmacokinetics Summary (ADME, bioavailability, tissue distribution)
Toxicology Summary (Single-dose, repeat-dose, genotoxicity, reproductive, and carcinogenicity studies)

3. Individual Study Reports (Module 4)

GLP-compliant study reports (e.g., toxicology, safety pharmacology, genotoxicity, carcinogenicity, immunogenicity)
Specialized reports for gene therapy and biologics, including:
- Biodistribution Studies
- Viral Shedding Studies
- Integration/Insertional Mutagenesis Reports
- Tumorigenicity and Reproductive Toxicity (if applicable)
Nonclinical Pharmacokinetic/ADME Reports

Templates and Authoring Standards

Techsol uses standardized templates based on:

ICH M4S and eCTD structure for small molecules and biologics
Gene Therapy / ATMP-specific templates integrating long-term follow-up (LTFU) and risk management sections

Content aligned with latest regulatory requirements:

US FDA eCTD v4.0
EMA Module 4 requirements and CAT recommendations for ATMPs
Japan PMDA and Health Canada eCTD adaptations

Non-Clinical Authoring Workflow at Techsol

1. Source Data Collection, and Authoring

Gather GLP-compliant study reports, bioanalytical data, and pharmacology summaries
Ensure traceability from raw data to CTD summaries

2. Drafting Non-Clinical Summaries and Overviews

Prepare Module 2.4 and 2.6 using Techsol’s regulatory templates
Integrate tabulated and graphical data for clarity

3. Internal QC and Peer Review

Line-by-line QC to ensure data accuracy, consistency with study reports, and adherence to ICH format
Cross-referencing with clinical protocols to ensure translational relevance

4. SME and Regulatory Review

Review by toxicologists, pharmacologists, and regulatory SMEs
Alignment with latest FDA and EMA guidance for non-clinical content

5. Finalization and eCTD Publishing & Submission

Integration into Module 4 for IND, NDA, or BLA submissions
eCTD validation before submission to health authorities

Common Challenges and Techsol Solutions

#	Challenges	Solutions
1	Inconsistent terminology and abbreviations across the source documents provided.	To ensure consistency and avoid redundancy across the non-clinical documents, standardized glossaries and abbreviation lists are used along with document harmonization, strategic planning, targeted cross-referencing, and content streamlining.
2	Difficulty aligning nonclinical findings with clinical safety conclusions.	Authoring of clear, evidence-based conclusions in Module 2.4, 2.6, and 4. Linking nonclinical safety signals to potential clinical risks or mitigation strategies.
3	Technical formatting errors in final deliverables.	Automated tools for document validation (bookmarks, hyperlinks, metadata), Pre-submission publishing checks for eCTD compliance.
4	Errors in tabulation or data presentation.	Dedicated QC and editorial teams to ensure technical accuracy and formatting consistency, automated cross-checks, and validation steps.

Expertise and Capabilities of Techsol

Qualified Nonclinical Medical Writers: Experts with advanced degrees (Ph.D., Pharm.D., M.Sc.) and cross-domain experience in pharmacology, toxicology, and DMPK
Regulatory Acumen: Proficiency in ICH, OECD, FDA, EMA, and WHO guidelines
Project Management Excellence: Streamlined communication, milestone tracking, and risk mitigation strategies
Tech-driven Workflow: Use of validated authoring templates, version tracking systems, and secure document management platforms (e.g., RIMS, Veeva Vault)