+353-1-416-8900REST OF WORLD
+44-20-3973-8888REST OF WORLD
1-917-300-0470EAST COAST U.S
1-800-526-8630U.S. (TOLL FREE)

Results for tag: "Regulatory Affairs"

Japan: Regulatory Compliance Requirements for Life Science Products - Webinar (Recorded) - Product Thumbnail Image

Japan: Regulatory Compliance Requirements for Life Science Products - Webinar (Recorded)

  • Webinar
  • August 2019
  • 120 Minutes
  • Japan
Process Validation - Overview of Why and How - Webinar (Recorded) - Product Thumbnail Image

Process Validation - Overview of Why and How - Webinar (Recorded)

  • Webinar
  • August 2019
  • 90 Minutes
  • Global
Raw Materials in Pharma/Biotech Production - Webinar (Recorded) - Product Thumbnail Image

Raw Materials in Pharma/Biotech Production - Webinar (Recorded)

  • Webinar
  • June 2019
  • 90 Minutes
  • Global
Supplier and Service Provider Controls: FDA Expectations - Webinar (Recorded) - Product Thumbnail Image

Supplier and Service Provider Controls: FDA Expectations - Webinar (Recorded)

  • Webinar
  • May 2019
  • 180 Minutes
  • Global
Design History Files and Technical Files/Design Dossiers - Meeting U.S. FDA CGMPS and the EU's MDD Requirements - Webinar (Recorded) - Product Thumbnail Image

Design History Files and Technical Files/Design Dossiers - Meeting U.S. FDA CGMPS and the EU's MDD Requirements - Webinar (Recorded)

  • Webinar
  • May 2019
  • 90 Minutes
  • United States, Europe United States, Europe
505(b)(2) NDAs - Webinar (Recorded) - Product Thumbnail Image

505(b)(2) NDAs - Webinar (Recorded)

  • Webinar
  • March 2019
  • 120 Minutes
  • Global
Verification vs. Validation in Regulated Industries - Webinar (Recorded) - Product Thumbnail Image

Verification vs. Validation in Regulated Industries - Webinar (Recorded)

  • Webinar
  • January 2019
  • 90 Minutes
  • Global
Meet the Tougher U.S. FDA CGMPs - Webinar (Recorded) - Product Thumbnail Image

Meet the Tougher U.S. FDA CGMPs - Webinar (Recorded)

  • Webinar
  • November 2018
  • 90 Minutes
  • United States
Establishing an Effective & Pragmatic Vendor Qualification Program for cGMP Compliance in the Pharmaceutical Industry - Webinar - Product Thumbnail Image

Establishing an Effective & Pragmatic Vendor Qualification Program for cGMP Compliance in the Pharmaceutical Industry - Webinar

  • Webinar
  • 90 Minutes
  • Global
From
Cell Cryopreservation Market By Type, By Application, By End User: Global Opportunity Analysis and Industry Forecast, 2023-2032 - Product Thumbnail Image

Cell Cryopreservation Market By Type, By Application, By End User: Global Opportunity Analysis and Industry Forecast, 2023-2032

  • Report
  • June 2023
  • 266 Pages
  • Global
From
Clinical Trials Audit Preparation. A Guide for Good Clinical Practice (GCP) Inspections. Edition No. 1 - Product Thumbnail Image

Clinical Trials Audit Preparation. A Guide for Good Clinical Practice (GCP) Inspections. Edition No. 1

  • Book
  • June 2010
  • 246 Pages
Extractables and Leachables. Characterization of Drug Products, Packaging, Manufacturing and Delivery Systems, and Medical Devices. Edition No. 1 - Product Thumbnail Image

Extractables and Leachables. Characterization of Drug Products, Packaging, Manufacturing and Delivery Systems, and Medical Devices. Edition No. 1

  • Book
  • October 2022
  • 448 Pages
The Fundamentals of Clinical Research. A Universal Guide for Implementing Good Clinical Practice. Edition No. 1 - Product Thumbnail Image

The Fundamentals of Clinical Research. A Universal Guide for Implementing Good Clinical Practice. Edition No. 1

  • Book
  • February 2022
  • 544 Pages
Leachables and Extractables Handbook. Safety Evaluation, Qualification, and Best Practices Applied to Inhalation Drug Products. Edition No. 1 - Product Thumbnail Image

Leachables and Extractables Handbook. Safety Evaluation, Qualification, and Best Practices Applied to Inhalation Drug Products. Edition No. 1

  • Book
  • February 2012
  • 700 Pages
Safety Risk Management for Medical Devices. Edition No. 2 - Product Thumbnail Image

Safety Risk Management for Medical Devices. Edition No. 2

  • Book
  • November 2021
Agricultural Nanobiotechnology. Biogenic Nanoparticles, Nanofertilizers and Nanoscale Biocontrol Agents. Woodhead Publishing Series in Food Science, Technology and Nutrition - Product Thumbnail Image

Agricultural Nanobiotechnology. Biogenic Nanoparticles, Nanofertilizers and Nanoscale Biocontrol Agents. Woodhead Publishing Series in Food Science, Technology and Nutrition

  • Book
  • April 2022
Loading Indicator

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