I will audit your ctd files for pharmaceutical products registration

About This Service

Do you need a professional review of your pharmaceutical CTD dossier to ensure accuracy, compliance, and clarity?

I am a qualified pharmacist with expertise in pharmaceutical formulation and regulatory documentation. I offer professional auditing, correction, and optimization of CTD dossiers to ensure high-quality regulatory submissions.

My goal is to help you reduce errors, improve document quality, and enhance the overall consistency and compliance of your submission.

Services Offered

CTD Regulatory Audit

I will review:

• CTD structure and organization
• Scientific and technical consistency
• Documentation errors and gaps
• Cross-module inconsistencies
• Overall regulatory compliance
• Clarity and professionalism of writing

Document Correction & Editing

I can:

• Correct scientific and technical errors
• Improve regulatory writing quality
• Rewrite unclear sections
• Harmonize document structure
• Check references, tables, and data presentation
• Enhance overall professional quality

CTD Module Support

Support available for:

• Module 1: Administrative information
• Module 2: Summaries
• Module 3: Quality (CMC)
• Review of non-clinical and clinical sections