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Pharma

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Posts in Tag: Pharma

  • What are the reference countries in SFDA?

    SFDA Reference Countries

  • How to submit a safety report ICSR to SFDA

    Submission of Individual Case Safety Reports (ICSRs) to SFDA

  • Signal Management Workshop (March 2023 Riyadh)

  • How to submit a PSUR to SFDA and what are the requirments?

    Periodic Safety Update Report (PSUR) Submission to SFDA

  • Product label and artwork requirements in Saudi Arabia according to SFDA.

    SFDA Labelling Requirements (SPC, PIL, IFU, Artworks)

  • Clinical trials CRO requirements

    SFDA Clinical Trials Requirements in Saudi Arabia

  • NDLP: Saudi Pharmaceutical Market is expected at $11.7 billion by 2030 (Medical Devices Included)

  • SFDA fees and charges for applications and services.

    SFDA Fees

  • Learn about pharmacovigilance and QPPV requirements by SFDA in Saudi Arabia

    Pharmacovigilance & QPPV Requirements in Saudi Arabia

  • SFDA-Variation types in the guidelines

    How to Submit an SFDA Variation Application? (Guidelines V. 6.3)

  • SFDA-Verification-Abridged-Procedure

    SFDA Verification & Abridged Drug Procedures

  • SFDA-Stability-Study-Requirements

    SFDA Stability Study Requirements

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