Pharmaceutical Drug Registration

Description

We specialize in Pharmaceutical Drug and Medicine Registration with the NPRA (National Pharmaceutical Regulatory Agency) in Malaysia. All prescription, OTC, and controlled medicines must be registered before marketing. Our services include dossier preparation (in CTD format), product classification, GMP compliance support, labeling review, and online submission . We also assist with bioequivalence (BE) study requirements, variations, and renewals. With deep regulatory expertise, we guide pharmaceutical companies—local and international—through each stage to ensure full compliance with Malaysian laws. Our goal is to help you achieve timely product registration while minimizing rejection risks and regulatory delays.

📌 What’s Included

• Dossier Preparation (CTD format)

• Product Classification

• GMP Compliance Support

• Labeling Review

• Online Submission to NPRA

• Bioequivalence (BE) Study Assistance

• Variation Handling & Renewal Services