Tag: CDSCO bioequivalence norms

BA-BE Studies: SOP for Compliance with ICH E6(R2) GCP Addendum – V 2.0 Standard Operating Procedure for Compliance with ICH E6(R2) GCP Addendum in BA/BE Studies Department BA-BE Studies SOP No. SOP/BA-BE/045/2025 Supersedes SOP/BA-BE/045/2022 Page No. Page 1 of 12 Issue Date 17/04/2025 Effective Date 20/04/2025 Review Date 17/04/2026 1. Purpose To define the process…

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BA-BE Studies: SOP for Trial Registration with EudraCT – V 2.0 Standard Operating Procedure for Trial Registration with EudraCT in BA/BE Studies Department BA-BE Studies SOP No. SOP/BA-BE/044/2025 Supersedes SOP/BA-BE/044/2022 Page No. Page 1 of 11 Issue Date 17/04/2025 Effective Date 20/04/2025 Review Date 17/04/2026 1. Purpose To define the process for registering BA/BE clinical…

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BA-BE Studies: SOP for Project Risk Identification and Mitigation – V 2.0 Standard Operating Procedure for Project Risk Identification and Mitigation in BA/BE Studies Department BA-BE Studies SOP No. SOP/BA-BE/043/2025 Supersedes SOP/BA-BE/043/2022 Page No. Page 1 of 12 Issue Date 17/04/2025 Effective Date 20/04/2025 Review Date 17/04/2026 1. Purpose To establish a structured approach for…

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BA-BE Studies: SOP for Setting Up eTMF (Electronic Trial Master File) – V 2.0 Standard Operating Procedure for Setting Up eTMF (Electronic Trial Master File) in BA/BE Studies Department BA-BE Studies SOP No. SOP/BA-BE/042/2025 Supersedes SOP/BA-BE/042/2022 Page No. Page 1 of 13 Issue Date 17/04/2025 Effective Date 20/04/2025 Review Date 17/04/2026 1. Purpose To define…

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BA-BE Studies: SOP for Study Timelines and Milestone Management – V 2.0 Standard Operating Procedure for Study Timelines and Milestone Management in BA/BE Studies Department BA-BE Studies SOP No. SOP/BA-BE/041/2025 Supersedes SOP/BA-BE/041/2022 Page No. Page 1 of 12 Issue Date 17/04/2025 Effective Date 20/04/2025 Review Date 17/04/2026 1. Purpose To define the process for planning,…

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BA-BE Studies: SOP for Establishing Quality Agreements with CROs – V 2.0 Standard Operating Procedure for Establishing Quality Agreements with CROs in BA/BE Studies Department BA-BE Studies SOP No. SOP/BA-BE/040/2025 Supersedes SOP/BA-BE/040/2022 Page No. Page 1 of 12 Issue Date 17/04/2025 Effective Date 20/04/2025 Review Date 17/04/2026 1. Purpose To define the procedure for establishing…

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BA-BE Studies: SOP for Third-Party Vendor Qualification (Labs, Courier) – V 2.0 Standard Operating Procedure for Third-Party Vendor Qualification (Labs, Courier) in BA/BE Studies Department BA-BE Studies SOP No. SOP/BA-BE/039/2025 Supersedes SOP/BA-BE/039/2022 Page No. Page 1 of 13 Issue Date 17/04/2025 Effective Date 20/04/2025 Review Date 17/04/2026 1. Purpose To define the standardized process for…

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BA-BE Studies: SOP for Clinical Trial Budget Preparation and Approvals – V 2.0 Standard Operating Procedure for Clinical Trial Budget Preparation and Approvals in BA/BE Studies Department BA-BE Studies SOP No. SOP/BA-BE/038/2025 Supersedes SOP/BA-BE/038/2022 Page No. Page 1 of 13 Issue Date 17/04/2025 Effective Date 20/04/2025 Review Date 17/04/2026 1. Purpose To define the procedure…

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BA-BE Studies: SOP for Review of Subject Recruitment Feasibility – V 2.0 Standard Operating Procedure for Review of Subject Recruitment Feasibility in BA/BE Studies Department BA-BE Studies SOP No. SOP/BA-BE/037/2025 Supersedes SOP/BA-BE/037/2022 Page No. Page 1 of 12 Issue Date 17/04/2025 Effective Date 20/04/2025 Review Date 17/04/2026 1. Purpose To define the procedure for reviewing…

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BA-BE Studies: SOP for Training of Study Staff on Protocol and GCP – V 2.0 Standard Operating Procedure for Training of Study Staff on Protocol and GCP in BA/BE Studies Department BA-BE Studies SOP No. SOP/BA-BE/036/2025 Supersedes SOP/BA-BE/036/2022 Page No. Page 1 of 13 Issue Date 17/04/2025 Effective Date 20/04/2025 Review Date 17/04/2026 1. Purpose…

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