1<!DOCTYPE html>
2
3Anonymous
4/bestp
5/bestp/domrep.nsf
64067A6BFB29578D90025858800467E42
8
9
10
11
12
13
140
15
16
17/bestp/domrep.nsf/products/db-developing-superior-regulatory-affairs-operations-structure-investment-service-levels?opendocument
18
19opendocument
203.237.186.116
21
22
23www.best-in-class.com
24/bestp/domrep.nsf
25DB




Products & Services Quality, Compliance and Regulatory Regulatory Affairs

Developing Superior Regulatory Affairs Operations: Structure, Investment and Service Levels

ID: 5621


Features:

4 Info Graphics

31 Data Graphics

390+ Metrics

2 Narratives


Pages/Slides: 45


Published: 2020


Delivery Format: Online PDF Document


 

License Options:
close

Single User: Authorizes use by the person who places the order or for whom the order was placed.

Sitewide: Authorizes use of the report for a geographic site. All people at site can view the report for a year and copies can be printed.

Corporate: Authorizes use for the entire company for a year and copies can be printed. No limitations for usage inside the company.




Buy Now

 


  • STUDY OVERVIEW
  • BENCHMARK CLASS
  • SPECIAL OFFER
Non-members: Click here to review a complimentary excerpt from “Developing Superior Regulatory Affairs Operations: Structure, Investment and Service Levels”

STUDY OVERVIEW

Regulatory Affairs groups play a critical role in ensuring that their organizations meet the stringent regulatory requirements pertaining to the development and commercialization of drugs and devices.

These groups must balance competing interests such as managing limited resources, ensuring product compliance, and delivering value to patients and healthcare providers.


Best Practices, LLC conducted this benchmarking research to probe how leading pharmaceutical and medical device companies are improving the effectiveness of their Regulatory Affairs functions to support their service and product portfolio. This study specifically benchmarks the structure, staffing, budget, processes, and service levels of Regulatory Affairs functions.

Regulatory Affairs leadership can refer to this study to identify the best practices employed by competitors in meeting the growing demands of the heavily regulated pharmaceutical and diagnostics market.


KEY TOPICS

  • Regulatory Affairs Staffing & Investment
  • Regulatory Affairs Structure
  • Regulatory Affairs Process
  • Regulatory Affairs Service Levels

KEY METRICS
  • Please estimate the total number of FTEs that work in different parts of your company's Regulatory Affairs functional area
  • Estimate the average number of direct reports at each supervisory level in your organization by area during 2019
  • How has your functional area headcount changed in the past 3 years?
  • How has the total spend of your company's Regulatory Affairs functional spending changed over the past 3 years?
  • What forces or issues have been driving the percentage changes in your company's functional staffing and spending during the past three years?
  • How is your Regulatory Affairs function structured in your company?
  • Estimate the percentage of your regulatory interactions with different regulatory agencies
  • Which countries’ regulatory agencies are the most important in the growth and future direction of your business?
  • How effective is each of the listed strategies or tactics in helping your Regulatory Affairs group improve interactions with regulatory agencies?
  • In which format is Regulatory intelligence and critical information delivered to internal stakeholders?
  • What specific services does the staff responsible for monitoring regulatory agencies provide?

SAMPLE KEY FINDINGS
  • Regulatory Affairs Staffing: Staffing for regulatory affairs in less-regulated companies tends to be about 0.5% of total corporate staffing, while regulatory staffing in companies with more regulations tends to be about 2%.

METHODOLOGY

Best Practices, LLC engaged 24 leaders from 22 life sciences and medical device companies in this research through a benchmarking survey. More than 80% of the benchmark class serves at the director level and above.


Industries Profiled:
Medical Device; Biopharmaceutical; Pharmaceutical; Medical; Technology; Research; Health Care; Biotech; Science


Companies Profiled:
3M - DDSD; Acceleron Pharma; Aesculap; Anesthetics Biomedical Inc.; Biotronik; Boston Scientific; Grifols; Halma; inStem; Johnson & Johnson; Lentigen Technology; Inc.; Minnetronix; NeedleTech Products Inc.; Onconova Therapeutics; PerkinElmer; Quest Medical; Radius Health; ReShape Lifesciences; Sartorius Stedim; Thermo Fisher Scientific; Verastem Oncology; Waters Corporation

If you purchase Best Practice Database document(s), you will have 30 days from the date of purchase to apply some or all of the cost of the document(s) toward the cost of a Full Access Individual, Pharma, Group or University Membership. Write us at DatabaseTeam@bestpracticesllc.com or call David Guinn at 919-767-9179 if you have any questions.