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Health Tech

At COGNISO, we specialise in Health Tech including Pharma Manufacturing and Distribution.

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Pharma Manufacturing

  • Risk Assessment

  • SOP Management

  • SOP Validation

  • Change Control Procedures

  • TGA and FDA Compliance

  • Zero Data Loss

Pharma Covigilance

  • Literature Search

  • Case Management

  • Finalisation

  • ICSR Submission

  • Aggregate Reporting

  • PSUR Submission

  • eCTD Submission

  • Safety Database

  • Follow up of ICSRs

  • RSI

  • Signal Management

  • MICC

  • Regulatory queries and responses

  • Commercials and invoicing

  • QPPV

  • Deputy QPPV

  • NPP

ERP Software - GMP Specific

  • CFR Compliant

  • Validated

  • Audit Trails

  • QMS Integrated

  • Electronically Signed

  • Cloud Hosted

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