Dossier Submission for the Global market

At Tactus Lifesciences, we specialize in Pharmaceutical Regulatory Affairs services, ensuring smooth registration of medicinal products worldwide. Our expert team navigates dynamic requirements, mitigates risks, and ensures timely approvals. With comprehensive support and accurate submissions, we assist global manufacturers in navigating regulatory complexities with confidence.

Expertise in Dossier Compilation

Our expertise in dossier compilation for various regulatory purposes, including Clinical Trial Applications, Orphan Drug Designations, Scientific Advice, and Marketing Authorization Applications. Our team excels in crafting comprehensive dossiers that meet submission deadlines and regulatory requirements with precision.

Tactus Lifesciences presents an array of all-encompassing and personalized regulatory solutions.
Dive into our specialized Dossier Templates for the Global Market services outlined below:

Dossier Compilation and submission to global health agencies.
Pre-submission meetings with the Agency
Deficiency response drafting and submission in eCTD.
DMF compilation and review.
Submission of Mutual Recognition Procedure/DCP-Europe/International Recognition Procedure (IRP)- UK for drug registration.
Marketing Authorization Application
Bridging report for PIL User testing (If applicable)
Variation compilation and submission
Extension of approved dossier to new regions
eCTD support and online Dossier filing to MOH.
User testing activities for EU submission.
ANDA/NDA/MAA site transfer activity and alternate vendor filing strategy.
Compiling, technical reviewing, finalizing, publishing, and filing the MAA submission.

Dossier Templates

We understand the importance of standardized CTD/eCTD dossier templates for regulatory submissions. At Tactus Lifesciences, we offer meticulously crafted templates for a wide range of regulatory applications, including MAAS, BLAs, NDAS, ANDAs, and more. Our templates are designed with key submission process:

Data Enrichment Toolkit

Encrypted with specific metadata, our templates guide authors in understanding regulatory expectations and drafting content for each section. This metadata is prepared by regulatory experts with real-time experience, ensuring alignment with FDA and EMA requirements.

Author-Centric Enhancements

Our templates come with pre-loaded formatting, standardized format elements, and customized toolbars to accelerate document creation. Authors can easily navigate through sections, reducing formatting time and ensuring consistency.

Content Flexibility Solutions

Configured considering features to streamline the industry best practices, our templates support content reuse for multiple applications with minimal rework. This ensures efficiency and consistency across submissions.

Inclusive User Guide

We provide an easy-to-understand user guide with each template package, empowering authors to maximize the features while drafting CTD sections.

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