Regulatory Support

Dossier Preparation & Regulatory Submission

At Magnificent Concept, we specialize in providing comprehensive dossier preparation and submission services that align with international regulatory requirements. Whether you're targeting domestic markets or pursuing approvals in regulated markets like the US, EU, GCC, or emerging countries, our experienced regulatory affairs team ensures that your product documentation is accurate, compliant, and submission ready.

We handle every aspect of dossier development with precision from collecting technical and clinical data to compiling and formatting the documents in CTD/eCTD formats.

Our Dossier Services Include:

• Technical data compilation for pharmaceutical products.

• Regulatory writing for Module 1 to 5 (as per ICH guidelines).

• Country-specific dossier formatting (WHO-GMP, EU-GMP, USFDA, etc.).

• Gap analysis and remediation of existing dossiers.

• Life cycle management for updating, renewing, and responding to regulatory queries.

• Coordination with local agents or licensing partners for submission and follow-up.

With a deep understanding of global regulatory frameworks, we help you reduce approval timelines, minimize compliance risks, and accelerate market entry.