Regulatory affairs

Regulatory Affairs Outsourcing Market - Global Industry Analysis, Size, Share, Growth, Trends, and Forecast 2018 - 2026

Retrieved on: 
Wednesday, November 7, 2018
Economy, Business, Economic globalization, Occupations, Regulatory affairs, Outsourcing

NEW YORK, Nov. 7, 2018 /PRNewswire/ -- Regulatory Affairs Outsourcing Market - (Services - Regulatory Submissions, Clinical Trial Applications and Product Registrations, Regulatory Writing and Publishing, Regulatory Consulting and Legal Representation) - Global Industry Analysis, Size, Share, Growth, Trends, and Forecast 2018 - 2026

Key Points: 
  • NEW YORK, Nov. 7, 2018 /PRNewswire/ -- Regulatory Affairs Outsourcing Market - (Services - Regulatory Submissions, Clinical Trial Applications and Product Registrations, Regulatory Writing and Publishing, Regulatory Consulting and Legal Representation) - Global Industry Analysis, Size, Share, Growth, Trends, and Forecast 2018 - 2026
    Global Regulatory Affairs Outsourcing Market: Overview
    The report on the global regulatory affairs outsourcing market provides analysis for the period between 2016 and 2026, wherein 2017 is the base year, and 2018 to 2026 is the forecast period.Data for 2016 has been included to provide historical information.
  • Ecosystem analysis which identifies key stakeholders in the regulatory affairs outsourcing market is covered in the report.
  • Global Regulatory Affairs Outsourcing Market: Scope of the Report
    The regulatory affairs outsourcing market has been segmented based on services and region.By services, the market is segmented into regulatory submissions; clinical trial applications and product registrations; regulatory writing and publishing; regulatory consulting and legal representation; and others.
  • Regulatory Affairs Outsourcing Market Analysis, by Services
    Additionally, the report provides cross-sectional analysis of the regulatory affairs outsourcing market with respect to the following geographical segments:

RepliCel Life Sciences Appoints Head of Clinical and Regulatory Affairs

Retrieved on: 
Tuesday, November 6, 2018
Occupations, Regulatory affairs

VANCOUVER, Nov. 06, 2018 /PRNewswire/ - RepliCel Life Sciences Inc. (OTCQB: REPCF) (TSXV: RP) (FRA:P6P2) ("RepliCel" or the "Company"), a company developing next-generation technologies in aesthetics and orthopedics, announces the appointment of European Clinical and Regulatory Affairs expert, Dr. Petra Goessens-Rueck, as Head of Clinical and Regulatory Affairs.

Key Points: 
  • VANCOUVER, Nov. 06, 2018 /PRNewswire/ - RepliCel Life Sciences Inc. (OTCQB: REPCF) (TSXV: RP) (FRA:P6P2) ("RepliCel" or the "Company"), a company developing next-generation technologies in aesthetics and orthopedics, announces the appointment of European Clinical and Regulatory Affairs expert, Dr. Petra Goessens-Rueck, as Head of Clinical and Regulatory Affairs.
  • Dr. Petra Goessens-Rueck has been a valuable consultant to RepliCel since its inception assisting with research, development, clinical and regulatory strategy in addition to managing regulatory submissions and most aspects of the Company's clinical trials.
  • Dr. Goessens-Rueck is a biotech consultant with more than 10 years' in-depth experience in the development of innovative cellular therapeutics.
  • View original content to download multimedia: http://www.prnewswire.com/news-releases/replicel-life-sciences-appoints-...
    SOURCE RepliCel Life Sciences Inc.

Marken Announces Global Brokerage Management Services For Clinical Trial Materials

Retrieved on: 
Tuesday, October 16, 2018
Health, Pharmaceutical industry, Clinical research, Clinical trial, Design of experiments, Drug discovery, Product testing, Brokerage firm, Regulatory affairs

Marken's oversight and compliance expertise ensures that time-sensitive and critical clinical shipments will avoid Customs and participating government agency-related delays.

Key Points: 
  • Marken's oversight and compliance expertise ensures that time-sensitive and critical clinical shipments will avoid Customs and participating government agency-related delays.
  • With a global approach to brokerage management for clinical trials, Marken is able to ensure Customs entries are filed accurately, compliantly and timely.
  • Dan Bell, Vice President, North America Operations & Global Regulatory Affairs, commented on the new service, "This is the first and only global brokerage service which is specifically tailored to clinical trials.
  • The expansion of global brokerage services in the suite of client offerings ensures that our experienced team are able to maintain complete control and visibility of clinical trial shipments across international borders.

Medical Device Report Presents Insights into Resource Allocation Needs in Quality, Regulatory Affairs, and Post-Market Surveillance Roles

Retrieved on: 
Monday, September 24, 2018
Clinical research, Health, Benchmarking, Strategic management, Clinical trials, Regulatory affairs, Benchmark, Medical research, Postmarketing surveillance, Human behavior

Best Practices, LLC undertook this benchmarking research to provide insights into how medical device companies are allocating resources in quality, regulatory affairs, and post market surveillance functions.

Key Points: 
  • Best Practices, LLC undertook this benchmarking research to provide insights into how medical device companies are allocating resources in quality, regulatory affairs, and post market surveillance functions.
  • Furthermore, this study highlights the number of CAPAs, NCEs, field actions, change requests, and complaints that participating companies experience.
  • This benchmarking report will help medical device leaders ascertain appropriate staff and budget for quality, regulatory affairs, or post market surveillance function(s).
  • Best Practices, LLC is a leading benchmarking, consulting and advisory services firm serving biopharmaceutical and medical device companies worldwide.

Two Day Seminar: Latin America Regulatory Compliance Requirements for Life Science Products Course - Focus on Brazil, Mexico, Argentina (November 28-29, 2018)

Retrieved on: 
Monday, September 17, 2018
Health, Biotechnology, Pharmaceutical industry, Biology, Regulatory compliance, Biopharmaceutical, Compliance, Medical device, Clinical research, Regulatory affairs, Food and Drug Administration

The "Latin America: Regulatory Compliance Requirements for Life Science Products (Focus: Brazil, Mexico, Argentina)" conference has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Latin America: Regulatory Compliance Requirements for Life Science Products (Focus: Brazil, Mexico, Argentina)" conference has been added to ResearchAndMarkets.com's offering.
  • This two-day comprehensive Course on Latin America Regulatory compliance requirements will cover topics ranging from pre-clinical and clinical requirements through product registration, amendments and renewals across Pharmaceuticals, Biologics, Medical Devices and Combination Products.
  • This course specifically focuses on the overall regulatory compliance requirements and procedures for Pharmaceuticals, Medical Devices, Biologics and Combination Products in Latin America.
  • Administrative staff responsible for ensuring compliance with regulatory filings and overall regulatory compliance requirements will also find this training highly relevant.

EMMA International Consulting Group, Inc. Welcomes Bob Marshall as VP of Business Development

Retrieved on: 
Monday, September 17, 2018
Quality assurance, Regulatory affairs, Medical device, Food and Drug Administration, Navistar International, Health, Human behavior, Government

International), a global leader in FDA Compliance consulting, welcomes Bob Marshall as their VP of Business Development.

Key Points: 
  • International), a global leader in FDA Compliance consulting, welcomes Bob Marshall as their VP of Business Development.
  • Mr. Marshall has over 25 years of experience in medical device product development, operations, contract manufacturing, quality assurance, and regulatory affairs.
  • Prior to joining the EMMA International team, Mr. Marshall served as Chief Editor for Med Device Online.
  • "I am pleased to welcome Bob Marshall to the EMMA International team," said Dr. Carmine Jabri, EMMA International's President and CEO.

Healthcare Regulatory Affairs Outsourcing Market: Global Industry Analysis, Size, Share, Growth, Trends and Forecast 2017 - 2025

Retrieved on: 
Monday, August 13, 2018
Economy, Business, Outsourcing, Economic globalization, B2B, International business, Telecommuting, Regulatory affairs, On-demand outsourcing

The global healthcare regulatory affairs outsourcing market is at a surge with the increase in demand for various services it offers.

Key Points: 
  • The global healthcare regulatory affairs outsourcing market is at a surge with the increase in demand for various services it offers.
  • There are also outsourcing services like clinical trial applications, and regulatory consulting and legal representations.
  • The rise in demand for services offered by healthcare regulatory affairs outsourcing market is also a result of increasing documentation during drug and device manufacturing.
  • There's an increase in the instances where prices of the services are not stated clearly in the healthcare regulatory affairs outsourcing market.

Medical Device Regulation Seminar: Eurasion Union, Russia and the CIS (London, United Kingdom - October 9-10, 2018)

Retrieved on: 
Thursday, July 19, 2018
International relations, World, Europe, United Nations General Assembly observers, Post-Soviet states, Trade blocs, Member states of the Commonwealth of Independent States, Member states of the United Nations, Eurasian Economic Union, Commonwealth of Independent States, Eurasia, Regulatory affairs

The "Medical Device Regulation in the Eurasion Union, Russia and the CIS" conference has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Medical Device Regulation in the Eurasion Union, Russia and the CIS" conference has been added to ResearchAndMarkets.com's offering.
  • A comprehensive overview of medical device regulatory affairs in Russia and the Eurasian Union.
  • The aim of this seminar is to provide a comprehensive overview of medical device regulatory affairs in Russia and the Eurasian Union.
  • Fully update you on the national regulations in Russia, Belarus, Kazakhstan, Ukraine and other CIS countries
    This seminar will be of particular interest to:

EU Pharmaceutical Regulations & Strategy Seminar (London, United Kingdom - October 30th-31st, 2018)

Retrieved on: 
Thursday, July 19, 2018
Occupations, Regulatory affairs, Regulation, Human behavior, Government, Health, Pharmaceuticals policy

The "EU Pharmaceutical Regulations & Strategy" conference has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "EU Pharmaceutical Regulations & Strategy" conference has been added to ResearchAndMarkets.com's offering.
  • This course will provide an up-to-date overview of the European pharmaceutical regulatory environment, procedures and obligations.
  • It will be of particular value as an introductory or refresher course for those involved in regulatory affairs or who interact with regulatory personnel to understand action time-lines and requests for information.
  • It will be of value for regulatory affairs personnel and also for those who interact with regulatory personnel in order to understand action time-lines and information requirements.

Two Day Course: Introduction to Veterinary Pharmacovigilance (London, United Kingdom - November 7th-8th, 2018)

Retrieved on: 
Thursday, July 19, 2018
Health, Pharmaceuticals policy, Healthcare quality, Clinical research, Clinical trials, Pharmacovigilance, Drug Safety, Regulatory affairs

This course will be beneficial for those new to veterinary pharmacovigilance, support staff and experienced personnel who require a better understanding of drug safety in their current role.

Key Points: 
  • This course will be beneficial for those new to veterinary pharmacovigilance, support staff and experienced personnel who require a better understanding of drug safety in their current role.
  • Adverse event monitoring and drug safety officers together with regulatory affairs and personnel from registration departments will find this seminar useful.
  • Did you know that we also offer Custom Research?
  • Visit our Custom Research page to learn more and schedule a meeting with our Custom Research Manager.