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CDSCO now requires online submission of Post Approval Changes for r-DNA products through the SUGAM portal, ending offline applications.
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The circular dated 23-Feb-26 provides updated guidelines and instructions for [specific audience] to ensure compliance and operational alignment. Key highlights include purpose, key instructions, timelines, and support contacts.
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India has proposed a 2026 amendment to simplify and streamline the registration process for ethics committees, aiming to improve efficiency and compliance in clinical research oversight.
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The Ministry of Health and Family Welfare has issued a draft notification proposing amendments to the New Drugs and Clinical Trials Rules, 2019, to regulate post-approval changes. The draft introduces a risk-based classification of quality changes and out
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The Central Drugs Standard Control Organization (CDSCO) has recently released a new draft guidance document (2026) specifically for the import of In-Vitro Diagnostic (IVD) medical devices.
Read moreProven 4-step Process: Consultation, Documentation, Submission, and Certification
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