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Products & Services Quality, Compliance and Regulatory Structure,Staffing and Execution

Developing Superior Regulatory and Global-Trade Compliance Operations: Investment and Service Levels

ID: 5622


Features:

4 Info Graphics

35 Data Graphics

360+ Metrics


Pages/Slides: 52


Published: 2020


Delivery Format: Online PDF Document


 

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

STUDY OVERVIEW

Regulatory and Global-Trade Compliance groups shoulder the responsibility of ensuring compliance with stringent regulations pertaining to the development, commercialization and market entry of drugs and devices across global markets.


These groups face a complex balancing act between managing scarce resources, ensuring product compliance, and delivering value to patients and healthcare providers across the globe.

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

Regulatory and Global-Trade Compliance leadership can refer to this study to identify the best practices employed by peers in meeting the evolving demands of the heavily regulated pharmaceutical and diagnostics market.


KEY TOPICS

  • Regulatory Compliance Staffing & Investment
  • Regulatory Compliance Structure
  • Regulatory Compliance Process & Service Levels
  • Global Trade Compliance Staffing & Investment
  • Global Trade Compliance Process & Service Levels

KEY METRICS
  • Please estimate the total number of FTEs that work in different parts of your company's Regulatory Compliance and Global Trade Compliance functional areas respectively
  • 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 and Global-Trade Compliance 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 Compliance function structured in your company?
  • When dealing strictly with the life science market segments, please select the phases across the entire regulatory value chain of a product in which your regulatory compliance is involved
  • For each of the selected points in the regulatory value chain of a product, which regulatory agencies do you engage with to prevent compliance issues?
  • Please estimate how many full-time equivalent employees (FTEs) are devoted to regulatory compliance in your business development group
  • Please estimate how much of the total regulatory compliance and trade compliance functions’ efforts are devoted to the listed activities
  • Which of the listed Global Trade Compliance software providers support your group?

SAMPLE KEY FINDINGS
  • Regulatory Compliance: Regulatory organizations typically interact with 3 to 9 agencies on average across the product lifecycle.

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.