Preparation of Drug Substance and Drug product registration dossier:
Regulatory Affairs
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Dossier preparation & submissions support in CTD [(Electronic common technical document (drug registration)] / eCTD, ACTD [Asian common technical dossier].
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NeeS [Non-eCTD electronic Submissions (NeeS)] formats to different Health Authorities of Regulated and Semi-Regulated markets like US-FDA, Health Canada, Europe, UK-MHRA, MCC-SA, ANVISA, ASEAN countries and ROW markets including Indian DCGI and CDSCO.
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Gap Analysis: Due diligence of the dossiers, DMF, and API supplier evaluation.
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Query response to health authorities.
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Life cycle management support for renewal, Annual report, Variation submissions, CEP monitoring, GMP status monitoring.
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Labeling management: PIL, SmPC, preparation, SmPC and PIL updates, bridging study and User testing in EU and RLD identification.
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Drugs import license for testing and analysis purpose (form11) /India.
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Import license and registration certificate for import of drugs (form 10 & RC in form41) /India.