Regulatory Affairs
End to end Regulatory Affairs services (dossier submissions (pre approval and post approval), product launch activity, and life-cycle management, compliance and audit support, and regulatory strategy) to pharma and healthcare industry globally
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Regulatory Labeling
End to end Labeling service (Structured product labeling SPLR4 i.e. Establishment Registration, NDC Labeler Code Request, GDUFA Self Identification Request, Drug Listing for PLR and Non-PLR, Artwork Management, Labeling components preparation)
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Regulatory Operations
End to end Regulatory Operations services (publishing and submission, document level publishing, submission level publishing, submission management, submission gateway assistance) to pharma and healthcare industry throughout the globe
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Training Program
A well defined online and class room training program established by Pharma experts for Regulatory Affairs and Regulatory Operations especially for pharma / life-science students and pharma professionals.
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