Pharmaceutical News & Regulatory Info

Ad/Promo Submissions to the FDA: Process, Transition, and Compliance with eCTD

Ad/Promo Submissions to the FDA: Process, Transition, and Compliance with eCTD

Celegence2024-11-25T05:46:10+00:00November 12th, 2024|

Streamlining IDMP Compliance with Effective Master Data Management

Streamlining IDMP Compliance with Effective Master Data Management

Celegence2025-02-13T13:32:27+00:00October 31st, 2024|

EU Clinical Trials – Transition from Directive to Regulation

EU Clinical Trials – Transition from Directive to Regulation

Shilpam Rajput2024-09-18T14:34:59+00:00August 13th, 2024|

Navigating the Complexities of Orphan Drug Designations: A Global Perspective

Navigating the Complexities of Orphan Drug Designations: A Global Perspective

Celegence2024-09-18T14:35:08+00:00August 7th, 2024|

eCTD Module 1 – In Depth Guide for Industry

eCTD Module 1 – In Depth Guide for Industry

Celegence2024-07-18T12:28:34+00:00July 16th, 2024|

A Complete Guide to Drug Master Files (DMFs): Submission Tips and Best Practices

A Complete Guide to Drug Master Files (DMFs): Submission Tips and Best Practices

Shilpam Rajput2024-07-10T10:19:12+00:00July 10th, 2024|

Pediatric Plans in Pharma: Regional Differences for Child Healthcare

Pediatric Plans in Pharma: Regional Differences for Child Healthcare

Celegence2024-08-06T10:00:44+00:00July 9th, 2024|

Stability Assessments as a Part of Bioanalytical Method Validation

Stability Assessments as a Part of Bioanalytical Method Validation

Shilpam Rajput2024-07-01T09:15:31+00:00June 28th, 2024|

A Comparative Look at the US, EU, and UK Global Health Authorities

A Comparative Look at the US, EU, and UK Global Health Authorities

Celegence2024-08-06T09:57:36+00:00June 7th, 2024|

How Expert Medical Writing Can Transform Regulatory Submissions

How Expert Medical Writing Can Transform Regulatory Submissions

Shilpam Rajput2024-06-07T11:25:46+00:00June 6th, 2024|

Pharmaceuticals Blog

Ad/Promo Submissions to the FDA: Process, Transition, and Compliance with eCTD

Ad/Promo Submissions to the FDA: Process, Transition, and Compliance with eCTD

Streamlining IDMP Compliance with Effective Master Data Management

Streamlining IDMP Compliance with Effective Master Data Management

EU Clinical Trials – Transition from Directive to Regulation

EU Clinical Trials – Transition from Directive to Regulation

Navigating the Complexities of Orphan Drug Designations: A Global Perspective

Navigating the Complexities of Orphan Drug Designations: A Global Perspective

eCTD Module 1 – In Depth Guide for Industry

eCTD Module 1 – In Depth Guide for Industry

A Complete Guide to Drug Master Files (DMFs): Submission Tips and Best Practices

A Complete Guide to Drug Master Files (DMFs): Submission Tips and Best Practices

Pediatric Plans in Pharma: Regional Differences for Child Healthcare

Pediatric Plans in Pharma: Regional Differences for Child Healthcare

Stability Assessments as a Part of Bioanalytical Method Validation

Stability Assessments as a Part of Bioanalytical Method Validation

A Comparative Look at the US, EU, and UK Global Health Authorities

A Comparative Look at the US, EU, and UK Global Health Authorities

How Expert Medical Writing Can Transform Regulatory Submissions

How Expert Medical Writing Can Transform Regulatory Submissions

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