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Demystifying CTD Module 2.4 & 2.5 for Generic Applications
In EU generic submissions, Modules 2.4 (Non-clinical Overview) and 2.5 (Clinical Overview) may seem straightforward — but they’re often the first sections read by assessors and can determine how smoothly the review proceeds....
Registration Of Drug Product In Phillippines 2025
In the Philippines, the registration of a drug product is regulated by the Food and Drug Administration (FDA Philippines) under the Department of Health (DOH). The registration process requires submission of a comprehensive dossier in the ASEAN Common Technical Dossier (ACTD) format, organized into four main parts...
Registration Of Drug Product In Singapore 2025
In Singapore, the registration of drug products is regulated by the Health Sciences Authority (HSA), under the Ministry of Health. The process requires submission of a Common Technical Document (CTD)-formatted dossier, comprising Modules 1 to 5 or ACTD format. Module 1 contains Singapore-specific administrative...
Registration Of Drug Product In Vietnam 2025
In Vietnam, the registration of a drug product is regulated by the Drug Administration of Vietnam (DAV), under the Ministry of Health (MOH).The registration process requires submission of a comprehensive dossier in the ASEAN Common Technical Dossier (ACTD) format, organized into four main parts (Parts I to IV), covering...
Registration Of Drug Product In Myanmar 2025
In Myanmar, drug product registration is regulated by the Food and Drug Administration (FDA Myanmar) under the Ministry of Health. All pharmaceutical products intended for import, manufacture, or sale in Myanmar must be registered with FDA Myanmar to ensure safety, efficacy, and quality. The registration process requires...
Structured Approach for EUGMP
Achieving EU GMP certification is essential for pharma manufacturers seeking entry into the European market. This step-by-step process — from GAP audit and CAPA implementation to EU inspection and certification — ensures compliance, quality, and global credibility. With expert guidance .....
