Corporate Banner
Satellite Banner
Technology
Networks
Scientific Communities
 
Become a Member | Sign in
Home>News>This Article
  News
Return

Increase in Pharmaceutical Companies Outsourcing Regulatory Affairs Budgets

Published: Thursday, January 10, 2013
Last Updated: Thursday, January 10, 2013
Bookmark and Share
A recent study by Cutting Edge Information shows outsourcing becoming more common for regulatory affairs tasks.

A majority of surveyed pharmaceutical companies outsource at least part of their regulatory affairs budget. This is up 5% from 2010, demonstrating that fewer drug companies are trying to keep such activities entirely in-house than before, according to a recent study by Cutting Edge Information. The study, “Regulatory Affairs: Safeguarding Submission Success and Product Development Strategy,” found that the industry is beginning to find benefit in hiring experienced contractors for many regulatory affairs tasks. The percentage of budgets being outsourced remains low—usually hovering between 10% and 20%, with a few outliers hiring vendors to perform more tasks than most companies tend to.

All surveyed Top 20 pharmaceutical companies reported outsourcing at approximately 10% of the overall regulatory affairs budget. Tasks that Top 20 companies outsourced included publishing, labeling or tracking changes to regulatory guidelines. Most companies also use vendors for post-market surveillance tasks, preferring to keep products that are still in development more close to the vest. However, contract research organizations (CROs) that Cutting Edge Information interviewed championed their ability to give investigational products the attention they deserve, despite drug manufacturers’ doubts.

“One CRO estimated its dedicated regulatory affairs headcount at 240 full-time equivalents (FTEs),” said Ryan McGuire, research team leader at Cutting Edge Information. “Their staff has experience with the regulations regarding global clinical trials. For some companies, it may be worth using this expertise during drug development.”

“Regulatory Affairs: Safeguarding Submission Success and Product Development Strategy” (http://www.cuttingedgeinfo.com/research/regulatory/market-approval/) contains resource benchmarks, strategic recommendations and best practices for building a strong regulatory affairs team and improving regulatory submission timelines. The study also delves into the topic further to find which regulatory functions companies commonly outsource, how much money they divert to them and why.

It is designed to guide key decision-makers to:
•    Overcome hurdles in your regulatory process to move your products to market as soon as possible.
•    Position regulatory affairs at the center of strategic activity.
•    Benchmark the most desired skills for regulatory affairs employees and hire accordingly.


Further Information
Access to this exclusive content is for Technology Networks Premium members only.

Join Technology Networks Premium for free access to:

  • Exclusive articles
  • Presentations from international conferences
  • Over 2,500+ scientific posters on ePosters
  • More Than 3,800+ scientific videos on LabTube
  • 35 community eNewsletters


Sign In



Forgotten your details? Click Here
If you are not a member you can join here

*Please note: By logging into TechnologyNetworks.com you agree to accept the use of cookies. To find out more about the cookies we use and how to delete them, see our privacy policy.

Related Content

Patient Enrollment is a Critical Cost Driver in Phase 1 Clinical Trials
Cutting Edge Information’s recent study of oncology trials revealed a strong correlation between number of patients and trial cost.
Wednesday, June 19, 2013
New Product Launches Double Medical Affairs Spending
Cutting Edge Information’s new study finds that some companies increase medical affairs budgets by 100% preceding a product launch.
Tuesday, April 16, 2013
New Product Planning Spend Up to Half their Time on BD
A new survey of drug manufacturers found that new product planning teams dedicate upwards of 50% of their time on business development activities.
Tuesday, January 29, 2013
Increase in Pharmaceutical Companies Outsourcing Regulatory Affairs Budgets
A recent study by Cutting Edge Information shows outsourcing becoming more common for regulatory affairs tasks.
Thursday, January 10, 2013
Increase in Pharmaceutical Companies Outsourcing Regulatory Affairs Budgets
A recent study by Cutting Edge Information shows outsourcing becoming more common for regulatory affairs tasks.
Thursday, January 10, 2013
Central and Eastern Europe Building Clinical Trial Success
Development teams benefit from tougher investigator standards and active patient populations, finds Cutting Edge Information.
Monday, February 14, 2011
Scientific News
NIH Study Finds Calorie Restriction Lowers Some Risk Factors for Age-Related Diseases
Two-year trial did not produce expected metabolic changes, but influenced other life span markers.
Immunotherapy Agent Benefits Patients with Drug-Resistant Multiple Myeloma in First Human Trial
Daratumumab proved generally safe in patients, even at the highest doses.
Low-level Arsenic Exposure Before Birth Associated with Early Puberty in Female Mice
Study examine whether low-dose arsenic exposure could have similar health outcomes in humans.
Inciting an Immune Attack On Cancer Cells
A new minimally invasive vaccine that combines cancer cells and immune-enhancing factors could be used clinically to launch a destructive attack on tumors.
‘Mutation-Tracking’ Blood Test for Breast Cancer
Scientists have developed a blood test for breast cancer able to identify which patients will suffer a relapse after treatment, months before tumours are visible on hospital scans.
Cellular Contamination Pathway for Heavy Elements Identified
Berkeley Lab scientists find that an iron-binding protein can transport actinides into cells.
Intensity of Desert Storms May Affect Ocean Phytoplankton
MIT study finds phytoplankton are extremely sensitive to changing levels of desert dust.
Common ‘Heart Attack’ Blood Test May Predict Future Hypertension
Small rises in troponin levels may have value as markers for subclinical heart damage and high blood pressure.
LaVision BioTec Reports on the Neuro Research on the Human Brain After Trauma
Company reports on the work of Dr Ali Ertürk from the Institute for Stroke and Dementia Research at LMU Munich.
NIH Study Shows No Benefit of Omega-3 Supplements for Cognitive Decline
Research was published in the Journal of the American Medical Association.
Scroll Up
Scroll Down
Skyscraper Banner

Skyscraper Banner
Go to LabTube
Go to eposters
 
Access to the latest scientific news
Exclusive articles
Upload and share your posters on ePosters
Latest presentations and webinars
View a library of 1,800+ scientific and medical posters
2,500+ scientific and medical posters
A library of 2,500+ scientific videos on LabTube
3,800+ scientific videos
Close
Premium CrownJOIN TECHNOLOGY NETWORKS PREMIUM FREE!