Developing Superior Global Quality, Regulatory, and Global-Trade Compliance Operations

These groups face a balancing act between managing resources, ensuring product quality and compliance, and adding value for patients and healthcare providers.

Best Practices, LLC conducted this benchmarking research to identify how leading pharmaceutical and medical device companies are improving the effectiveness of their Quality, Regulatory, and Global-Trade Compliance functions to support their service and product portfolio. This report also identifies effective structures, staffing levels, budget levels, processes, development and designs, and service levels.

Study Snapshot

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.

Key topics covered in this report include:

• Quality Assurance
  
  • Quality Assurance Staffing & Investment

• Quality Control
  
  • Quality Control Staffing & Investment
  • Structure
  • Process
  • Development & Design
  • Service Levels

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

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

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

• Quality Assurance Span of Control: In Quality Assurance, mid-level management has a comparatively wider span of control indicating multiple responsibilities are carried at this level.

• Quality Control Approaches: Process controls / analysis and risk management tactics are the most often-used approaches to ensure quality control.

• Regulatory Affairs Staffing Trend Drivers & Insights: Regulatory Affairs sees changes in staffing largely due to new regulations or newly launched products.

• Regulatory Compliance Responsibilities Proportion: In-line with importance, compliance spends most efforts on reviewing marketing material.

Sr. No.	Topic	Slide No.
I.	Overview	pgs. 3-5
	Objectives, Methodology & Topics	pg. 4
	Universe of Learning	pg. 5
II.	Quality Assurance	pg. 6
	Staffing & Investment	pgs. 7-17
III.	Quality Control	pg. 18
	Staffing & Investment	pgs. 19-27
	Structure	pgs. 28-36
	Process	pgs. 37-49
	Development & Design	pgs. 50-54
	Service Levels	pgs. 55-62
IV.	Regulatory Affairs	pg. 63
	Staffing & Investment	pgs. 64-73
	Structure	pgs. 74-81
	Process	pgs. 82-87
	Service Levels	pgs. 88-91
V.	Regulatory Compliance	pg. 92
	Staffing & Investment	pgs. 93-102
	Structure	pgs. 103-105
	Process	pgs. 106-109
	Service Levels	pgs. 110-113
VI.	Global Trade Compliance	pg. 114
	Staffing & Investment	pgs. 115-123
	Processes & Service Levels	pgs. 124-127
VII.	Benchmark Class Profile	pgs. 128-136
VIII.	About Best Practices, LLC	pg. 137

• Quality Assurance FTE and investment as a percentage of corporate FTEs and corporate revenue respectively
• Total number of FTEs that work in different parts of the company's Quality Assurance functional area
• Average number of direct reports at each supervisory level in the organization by area during 2019
• Quality Assurance span of control
• Change in Quality Assurance headcount in the past 3 years
• Quality Assurance staffing trend drivers and insights
• Quality Assurance functional spend, and reported spend
• Change in Quality Assurance spending over the past 3 years
• Quality Assurance spending trend drivers and insights
• Agility in M&A and/or market global expansion

• Quality Control FTE and investment as a percentage of corporate FTEs and corporate revenue respectively
• Total number of FTEs that work in different parts of the company's Quality Control functional area
• Average number of direct reports at each supervisory level in the organization by area during 2019
• Quality Control span of control
• Change in Quality Control headcount in the past 3 years
• Quality Control staffing and spending trend drivers and insights
• Quality Control functional spend, and reported spend
• Change in Quality Control spending over the past 3 years

• Structure of Quality function within benchmark companies
• Strengths and weakness of Quality structure
• Approaches used to ensure the Quality attributes of products
• Responsibilities funded and managed by Quality function
• Scope of design and quality responsibilities for the Quality organization
• Scope of audit and inspection responsibilities for the Quality organization
• Scope of product and project responsibilities for the Quality organization
• Scope of other responsibilities for the Quality organization

• Maturity of Cost of Quality function
• Optimum allocation of Quality resources
• Percentage of total Quality function budget allocated to the listed critical Quality channels
• Expected change in percentage allocations of total Quality function budget for each of the listed key Quality channels during the next 12 to 24 months
• Key drivers impacting increase and decrease in quality cost
• Compliance factors increasing Quality support spending within the next 12 to 24 months
• Complexity factors increasing Quality support spending within the next 12 to 24 months
• Process management factors increasing Quality support spending within the next 12 to 24 months
• Continuous improvement factors increasing Quality support spending within the next 12 to 24 months
• Simplification factors increasing Quality support spending within the next 12 to 24 months
• Regulatory factors decreasing Quality support spending within the next 12 to 24 months
• Centralization of key organizations related to Quality operations

• Methods used in development and design control process
• Impact of the listed factors on Quality during product development
• Integration of risk management and design controls (or similar requirements) into new product development (NPD) process
• Incorporation of listed post-market data into new product development

• Number of open CAPAs and NCEs processed per million in revenue
• CAPA cycle times
• Number of potential field evaluations and actions experienced by Quality organizations in 2019
• Documents reviewed / approved by Software Quality personnel
• Document controls and change levels
• Average number of change requests or engineering change orders reviewed and assessed by the Quality organization per year
• Incorporation of listed KPIs (key performance indicators) into a dashboard for assessing Quality performance

• Regulatory Affairs FTE and investment as a percentage of corporate FTEs and corporate revenue respectively
• Total number of FTEs that work in different parts of the company's Regulatory Affairs functional area
• Average number of direct reports at each supervisory level in the organization by area during 2019
• Regulatory Affairs span of control
• Change in Regulatory Affairs headcount in the past 3 years
• Regulatory Affairs staffing trend drivers and insights
• Regulatory Affairs functional spend, and reported spend
• Change in Regulatory Affairs spending over the past 3 years
• Regulatory Affairs spending trend drivers and insights

• Structure of Regulatory Affairs function within benchmark companies
• Strengths and weakness of Regulatory Affairs structure
• Ongoing Regulatory challenges being experienced by benchmark companies
• Percentage of regulatory interactions with different regulatory agencies
• Regulatory Affairs responsibilities matrix
• Regulatory Affairs responsibilities – Lead role, support role, and no role
• Locations of Regulatory Affairs responsibilities

• Agencies Monitored vs. Interaction, Future Impact
• Countries in which Regulatory Affairs groups monitor the activities of regulatory agencies and interactions of Regulatory Affairs groups with regulatory agencies
• Countries whose regulatory agencies have the most impact on the growth and future direction of business
• Effective strategies or tactics in helping Regulatory Affairs group improve its interactions with regulatory agencies
• Format in which regulatory intelligence and critical information is delivered to internal stakeholders

• Staff responsibilities associated with monitoring regulatory agencies
• Organizational design for monitoring of regulatory agencies and surveillance frequency
• Specific services provided by the staff responsible for monitoring regulatory agencies, and benefits of monitoring regulatory agencies

• Regulatory Compliance FTE and investment as a percentage of corporate FTEs and corporate revenue respectively
• Total number of FTEs that work in different parts of the company's Regulatory Compliance functional area
• Regulatory Compliance span of control
• Average number of direct reports at each supervisory level in the organization by area during 2019
• Change in Regulatory Compliance headcount in the past 3 years
• Regulatory Compliance staffing trend drivers and insights
• Regulatory Compliance functional spend, and reported spend
• Change in Regulatory Compliance spending over the past 3 years
• Regulatory Compliance spending trend drivers and insights

• Structure of Regulatory Compliance function within benchmark companies
• Strengths and weakness of Regulatory Compliance structure

• Phase-wise involvement of Regulatory Compliance across the entire regulatory value chain of a product - Life science market segments, and Regulatory Compliance activity proportion in life sciences across phases
• Regulatory agencies engaged by benchmark companies to prevent compliance issues - Life science market segments
• Representation of Regulatory Compliance in business development function, and Number of full-time equivalent employees (FTEs) devoted to regulatory compliance in business development group

• Regulatory Compliance responsibilities vs. proportion
• Activities performed by the Regulatory Compliance function
• Amount of Regulatory Compliance function’s efforts devoted to the listed activities

• Global Trade Compliance FTE and investment as a percentage of corporate FTEs and corporate revenue respectively
• Total number of FTEs devoted to Global Trade compliance
• Global Trade Compliance span of control
• Change in Global Trade Compliance headcount in the past 3 years
• Global Trade Compliance staffing trend drivers and insights
• Global Trade Compliance functional spend, and reported spend
• Change in Global Trade Compliance spending over the past 3 years
• Global Trade Compliance spending trend drivers and insights

• Amount of Trade Compliance function’s efforts devoted to the listed activities
• Trade trend drivers and insights, and Trade Compliance in new markets
• Representation of Trade Compliance in business development function, and software providers for Global Trade Compliance

• Industries served and focus areas of benchmark companies
• Therapeutic area representation of the benchmark class
• Job titles and operational responsibility of benchmark participants
• Product area representation of the benchmark class
• Total number of corporation-wide FTEs supporting benchmark companies' total revenues in 2019 or in the most recent fiscal year; Product area staffing mix reflecting portfolio complexity
• Revenue unit and annual revenue of the benchmark class
• Mix of industries served by the benchmark class; Product area revenue mix reflecting portfolio complexity
• Region-wise sales breakdown of benchmark companies