What are CTD & ACTD Dossier Preparation Services?
Our services include preparation of CTD/ACTD dossiers (Modules 1–5), eCTD/NeeS publishing, gap analysis, and localization for health authorities, ensuring global regulatory compliance.
CTD & ACTD Dossier Preparation for Global Submissions
Accurate, Compliant, and Market-Ready Dossiers
At Indivirtus Healthcare Services Pvt. Ltd., our CTD and ACTD Dossier Preparation services provide end-to-end support for pharmaceutical companies targeting global markets. We deliver compliant CTD/ACTD dossiers (Modules 1–5), eCTD/NeeS publishing, and localization, ensuring regulatory readiness for ICH, ASEAN, GCC, and ROW submissions.
Why is it Critical?
Compliant dossiers ensure regulatory approval, minimize submission delays, and facilitate market entry across ICH, ASEAN, GCC, and ROW markets.
Our Role in Your Success
As a trusted CRO, Indivirtus Healthcare Services delivers expert-led dossier solutions, providing accurate, regulator-ready submissions to support global market authorization.
Our Expert Dossier Approach
At Indivirtus Healthcare Services, our CTD and ACTD Dossier Preparation services are led by certified regulatory experts with global submission expertise. We prepare comprehensive CTD/ACTD dossiers, publish in eCTD/NeeS formats, conduct gap analyses, and localize Module 1 for specific health authority requirements.
Our structured approach ensures submission-ready dossiers, aligning with ICH M4, ASEAN ACTD, US FDA, EMA, CDSCO, TGA, and other global standards for efficient regulatory approvals.
Dossier Preparation Deliverables
Complete CTD or ACTD Dossier (Modules 1–5): Comprehensive, compliant documentation.
Formatted eCTD/NeeS Output: Submission-ready electronic formats.
Gap Analysis Report: Detailed assessment to address compliance gaps.
Localized Module 1 per Authority: Region-specific administrative documentation.
Submission-Ready Archive Package: Organized files for regulatory submission.
Regulatory Compliance & Global Standards
Our CTD and ACTD Dossier Preparation services align with stringent global standards, ensuring your submissions are regulator-ready and compliant with international markets. By adhering to industry-leading guidelines, we deliver solutions that enhance approval success.
- ICH M4: Global standards for Common Technical Document structure.
- ASEAN ACTD Guidelines: Standards for Southeast Asian market submissions.
- US FDA eCTD: U.S. regulations for electronic submission formats.
- EMA eCTD: European standards for electronic dossier submissions.
- CDSCO CTD: Indian regulations for dossier preparation.
- TGA CTD/NeeS: Australian standards for dossier submission formats.
Applications & Use Cases
Our CTD and ACTD Dossier Preparation services are essential for pharmaceutical companies targeting global market authorization. Ideal for new drugs, biologics, and generics, our solutions support regulatory submissions across ICH, ASEAN, GCC, and ROW markets. Key use cases include preparing dossiers for FDA/EMA approvals, localizing submissions for CDSCO, and ensuring compliance for TGA filings.
Why Choose Indivirtus Healthcare
Indivirtus Healthcare Services is a trusted partner for pharmaceutical companies, delivering expert-led dossier preparation solutions backed by certified regulatory professionals with global experience. Our services ensure scientifically defensible outcomes, rapid delivery, and strict confidentiality to protect your proprietary information.
With a commitment to industry best practices, we empower your organization with compliant, efficient dossier submissions, driving regulatory success and market access.
Frequently Asked Questions
Frequently Asked Questions
What is the difference between CTD and ACTD?
CTD is the ICH standard used globally, while ACTD is a modified format used in ASEAN countries. Both include Modules 1–5, but differ in structure and content detail.
Do you support eCTD publishing?
Yes, we provide eCTD and NeeS publishing using validated software tools compatible with regulatory authority gateways like FDA ESG, EMA, and others.
What documents are required for CTD preparation?
We typically need administrative data, CMC documentation, nonclinical/clinical reports, labeling, and any prior regulatory correspondence or commitments.
Can you localize Module 1 for different regions?
Yes, we customize Module 1 for each country or region to reflect national requirements such as labeling, forms, and local agent information.
How long does CTD or ACTD compilation take?
Timelines range from 2 to 6 months depending on data availability, complexity, and market. Expedited timelines are possible for streamlined products.
What do CTD & ACTD Dossier Preparation services include?
Our services include preparation of CTD/ACTD dossiers (Modules 1–5), eCTD/NeeS publishing, gap analysis, localized Module 1, and submission-ready archives.
Who benefits from CTD & ACTD Dossier Preparation services?
Pharmaceutical companies targeting global market authorization for new drugs, biologics, or generics benefit from our tailored dossier solutions.
How do these services ensure regulatory compliance?
Our services align with ICH M4, ASEAN ACTD, US FDA eCTD, EMA eCTD, CDSCO CTD, and TGA CTD/NeeS standards, ensuring global compliance.
What deliverables are provided with the service?
Clients receive complete CTD/ACTD dossiers, eCTD/NeeS outputs, gap analysis reports, localized Module 1, and submission-ready archives.
Can the dossier preparation services be customized for our needs?
Yes, our services are tailored to your specific product, market, and regulatory requirements, ensuring compliant and effective submissions.
How do the services support global market entry?
We prepare region-specific dossiers, publish in compliant formats, and localize documentation to ensure seamless approvals across global markets.