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Results for tag: "Regulatory Affairs"

3-Hour Virtual Seminar on Master Validation Plan - The Unwritten Requirements - Webinar (Recorded) - Product Thumbnail Image

3-Hour Virtual Seminar on Master Validation Plan - The Unwritten Requirements - Webinar (Recorded)

  • Webinar
  • May 2023
  • 180 Minutes
  • Global
From
Medical Devices Contract Research Organizations Market by Target Therapeutic Area, Scale of Operation, Device Class, Type of Clinical Service Offered, Type of Preclinical Service Offered, and Key Geographies: Industry Trends and Global Forecasts, 2022-2035 - Product Thumbnail Image

Medical Devices Contract Research Organizations Market by Target Therapeutic Area, Scale of Operation, Device Class, Type of Clinical Service Offered, Type of Preclinical Service Offered, and Key Geographies: Industry Trends and Global Forecasts, 2022-2035

  • Report
  • September 2022
  • 552 Pages
  • Global
From
Life Science Filtration Global Market - Forecast to 2028 - Product Thumbnail Image

Life Science Filtration Global Market - Forecast to 2028

  • Report
  • March 2022
  • 410 Pages
  • Global
From
3D Cell Culture Global Market - Forecast to 2028 - Product Thumbnail Image

3D Cell Culture Global Market - Forecast to 2028

  • Report
  • February 2022
  • 391 Pages
  • Global
From
Cell-Based Assays Global Market - Forecast to 2025 - Product Thumbnail Image

Cell-Based Assays Global Market - Forecast to 2025

  • Report
  • May 2019
  • Global
From
U.K. Biotechnology & Pharmaceutical Services Outsourcing Market Size, Share & Trends Analysis Report By Service (Consulting, Regulatory Affairs), By End-use (Pharma, Biotech), And Segment Forecasts, 2021 - 2028 - Product Thumbnail Image

U.K. Biotechnology & Pharmaceutical Services Outsourcing Market Size, Share & Trends Analysis Report By Service (Consulting, Regulatory Affairs), By End-use (Pharma, Biotech), And Segment Forecasts, 2021 - 2028

  • Report
  • November 2021
  • 100 Pages
  • United Kingdom
From
Nordic Regulatory Affairs Market Size, Share & Trends Analysis Report by Service, by Service Provider, by Company Size, by Category, by Product Stage, by Indication, by End-use, by Country and Segment Forecasts, 2021 - 2028 - Product Thumbnail Image

Nordic Regulatory Affairs Market Size, Share & Trends Analysis Report by Service, by Service Provider, by Company Size, by Category, by Product Stage, by Indication, by End-use, by Country and Segment Forecasts, 2021 - 2028

  • Report
  • March 2021
  • 114 Pages
  • Denmark, Finland, ... Denmark, Finland, Iceland, Norway, Sweden
From
UAE Contract Manufacturing Organizations Market, By Region, Competition, Forecast and Opportunities, 2018-2028F - Product Thumbnail Image

UAE Contract Manufacturing Organizations Market, By Region, Competition, Forecast and Opportunities, 2018-2028F

  • Report
  • November 2023
  • 77 Pages
  • United Arab Emirates United Arab Emirates
From
Contract Research Organization Market - Growth, Trends, COVID-19 Impact, and Forecasts (2023 - 2028) - Product Thumbnail Image

Contract Research Organization Market - Growth, Trends, COVID-19 Impact, and Forecasts (2023 - 2028)

  • Report
  • April 2023
  • 115 Pages
  • Global
From
The US FDA QMSR Transition - 21 CFR 820 and ISO 13485 (Recorded) - Product Thumbnail Image

The US FDA QMSR Transition - 21 CFR 820 and ISO 13485 (Recorded)

  • Training
  • February 2024
  • 90 Minutes
  • United States
From
Good Documentation Practice and Record Keeping Regulations (FDA & EMA) - Webinar (Recorded) - Product Thumbnail Image

Good Documentation Practice and Record Keeping Regulations (FDA & EMA) - Webinar (Recorded)

  • Webinar
  • January 2022
  • 60 Minutes
  • Global
6-Hour Virtual Seminar on eCTD Submissions of IND/NDA to the US FDA, EU and Canada - Webinar (Recorded) - Product Thumbnail Image

6-Hour Virtual Seminar on eCTD Submissions of IND/NDA to the US FDA, EU and Canada - Webinar (Recorded)

  • Webinar
  • June 2021
  • 6 Hours
  • Canada, United States, ... Canada, United States, Europe
From
eCTD Submissions - Fundamentals and Process (Recorded) - Product Thumbnail Image

eCTD Submissions - Fundamentals and Process (Recorded)

  • Training
  • February 2024
  • 60 Minutes
  • Global
From
Pharma 4.0: A Different Way to Approach GxP Products, Systems, and Compliance with FDA (Recorded) - Product Thumbnail Image

Pharma 4.0: A Different Way to Approach GxP Products, Systems, and Compliance with FDA (Recorded)

  • Training
  • April 2023
  • 2 Days
  • Global
From
US FDA Medical Device QSR, 21 CFR 820 and Quality Management System - Webinar (Recorded) - Product Thumbnail Image

US FDA Medical Device QSR, 21 CFR 820 and Quality Management System - Webinar (Recorded)

  • Webinar
  • March 2022
  • 90 Minutes
  • United States
Essentials Of USP Microbiology - Reading Between the Lines of the USP General and Information Microbiology Chapters (Recorded) - Product Thumbnail Image

Essentials Of USP Microbiology - Reading Between the Lines of the USP General and Information Microbiology Chapters (Recorded)

  • Training
  • October 2021
  • 2 Days
  • Global
From
6-Hour Virtual Seminar on EU Regulatory Affairs Strategy During Development of Medicinal Products - Webinar (Recorded) - Product Thumbnail Image

6-Hour Virtual Seminar on EU Regulatory Affairs Strategy During Development of Medicinal Products - Webinar (Recorded)

  • Webinar
  • June 2021
  • 6 Hours
  • Europe
From
Performing an Effective, Robust and Compliant Sterility Failure Investigation: How to Avoid Common Mistakes - Webinar (Recorded) - Product Thumbnail Image

Performing an Effective, Robust and Compliant Sterility Failure Investigation: How to Avoid Common Mistakes - Webinar (Recorded)

  • Webinar
  • September 2019
  • 120 Minutes
  • Global
Surviving an FDA Sponsor Inspection - Training for Success - Webinar (Recorded) - Product Thumbnail Image

Surviving an FDA Sponsor Inspection - Training for Success - Webinar (Recorded)

  • Webinar
  • August 2019
  • 180 Minutes
  • Global
Supplier Quality Assurance Agreements: Why a General Supply Agreement May Not Be Enough with Some Suppliers - Webinar (Recorded) - Product Thumbnail Image

Supplier Quality Assurance Agreements: Why a General Supply Agreement May Not Be Enough with Some Suppliers - Webinar (Recorded)

  • Webinar
  • May 2019
  • 90 Minutes
  • Global
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Regulatory Affairs in the biotechnology industry is the process of obtaining and maintaining approval from regulatory authorities for the development, manufacture, and marketing of biotechnology products. This includes the submission of applications, such as Investigational New Drug (IND) applications, New Drug Applications (NDAs), and Biologics License Applications (BLAs). Regulatory Affairs professionals are responsible for ensuring that biotechnology products comply with applicable laws and regulations. Regulatory Affairs professionals must have a thorough understanding of the regulatory environment and the ability to interpret and apply regulations to the development and marketing of biotechnology products. They must also be able to effectively communicate with regulatory authorities and other stakeholders. Companies in the Regulatory Affairs market in the biotechnology industry include Parexel, Quintiles, Covance, PRA Health Sciences, and Charles River Laboratories. Show Less Read more