CTD Dossier Preparation
Complete CTD dossiers (Modules 1–5) tailored for LATAM, Africa, Europe, and other regions — compliant with FDA, EMA, CDSCO, and global standards.
We specialize in high-quality regulatory dossier services that streamline the approval process for pharmaceuticals, medical devices, cosmetics, and nutraceuticals — ensuring full compliance with global and regional standards.
From CTD/eCTD/ACTD preparation to regulatory submissions, our expert team delivers precise, submission-ready dossiers that meet requirements of authorities like FDA, EMA, CDSCO, and others.
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We offer comprehensive, region-specific dossier preparation and submission support:
Complete CTD dossiers (Modules 1–5) tailored for LATAM, Africa, Europe, and other regions — compliant with FDA, EMA, CDSCO, and global standards.
Country-specific document preparation, formatting, validation, and electronic/paper submission to accelerate product approvals worldwide.
Conversion to compliant eCTD format, technical validation, lifecycle management, and efficient submission to global authorities.
High-quality DMFs for APIs, excipients, and packaging materials — supporting product registrations with detailed manufacturing and stability data.
Ensuring full regulatory compliance to minimize risks, avoid delays, and secure successful market approvals globally.
Preparation of PMF, DMF, technical files, and full regulatory support for timely registration and market access of medical devices in India and globally.
We stand out for our proven track record and commitment to excellence:
Successful registration of 100+ products — from small molecules to biologics and vaccines — through strict quality and compliance focus.
Accurate formatting, technical validation, and seamless eCTD publishing for EMA, FDA, GCC, and other authorities.
Expert team with deep knowledge of global regulations — providing proactive solutions and risk mitigation for smooth approvals.
With deep expertise in CTD, ACTD, and eCTD dossier preparation and submission, Medwisdom Lifescience is your trusted partner for global regulatory success. Contact us today to accelerate your product journey from planning to worldwide registration.
Get Started NowFind quick answers to common questions about our regulatory dossier services.
Contact UsWe provide full support for:
Yes — we offer complete support for both paper-based and electronic (eCTD) submissions to regulatory authorities worldwide.
Our dossier preparation services typically include:
Cost varies based on:
Contact us for a personalized quote tailored to your project.
With proven expertise in CTD, ACTD, and eCTD dossier preparation and submission, Medwisdom Lifescience is your trusted partner for global regulatory success. Reach out today to accelerate your product from planning to worldwide registration.
Get Started Now