Skip to main content
  • login
  • contact
  • language
    • English
    • Français
    • Español
    • Português
    • Deutsch
    • 简体中文
    • 日本語
  • search
X
GEP Logo GEP Logo
  • Company
    • Leadership
    • Customers
    • Partners
    • Sustainability at GEP
    • News
    • Events
    • Culture
    • Mission & Vision
    • Awards & Recognition
  • Solutions
    • Strategy
      • Procurement Consulting  
        • Procurement Transformation
        • Digital Procurement Transformation
        • Opportunity Assessment
        • M & A Services
        • Strategic Cost Management
        • Supply Risk Management
      • Supply Chain Consulting  
        • Environmental, Social and Governance
        • Socially Responsible Sourcing
        • Supply Chain Strategy
        • Supply Chain Diagnostics
        • Inventory Optimization
        • Network Optimization
      Software
      • GEP SMART  
        • Procurement Software
        • Direct Procurement Software
        • Indirect Procurement Software
        • Digital Procurement Transformation
        • Master Data Management
        • AP Automation
        • Spend Management
        • SMART S2P Technology
      • GEP NEXXE  
        • Supply Chain Visibility and Execution
        • Supply Chain Planning
        • Supply Chain Collaboration
        • Supply Chain Control Tower
        • Should-Cost Modeling
        • Inventory and Warehouse Management
      • GEP CLICK  
      • GEP MINERVA  
      Managed Services
      • Procurement Outsourcing  
        • Source-to-Contract
          • Spend Analysis
          • Strategic Sourcing
          • Category Management
          • Supply Market Intelligence
          • Tail-Spend Management
          • Procurement Support Services
        • Procure-to-Pay
          • Cost Recovery & Invoice Auditing
          • Accounts Payable
      • Supply Chain Outsourcing  
        • Planning & Forecasting
        • Inventory Management
        • Logistics Management
        • Supply Chain Data Management
        • Supply Chain Risk Management
  • Industries
    • Automotive
    • Chemicals
    • Consumer Packaged Goods
    • Energy & Utilities
    • Financial Services
    • Government & Nonprofit
    • Industrial Manufacturing
    • Life Sciences
    • Oil & Gas
    • Retail
    • Telecommunications, Media & Technology
    • High-Tech
    • Media & Entertainment
    • Software, Social & Platforms
    • Telecom
    • Travel & Hospitality
  • Knowledge Bank
    • Digital Transformation
    • Software & Technology
    • Strategy & Planning
    • Operations
    • Procurement
    • Sustainability
    • Insights From the Top
    • COVID-19 Resource Center
    • Inflation Strategies
  • Careers
    • Join Us
    • GEP Per Se
    • Campus Connect
  • Partners
   
  • GEP Strategy ›
    • GEP Strategy
    • ‹ Back
      • Procurement Consulting ›
        • Procurement Consulting
        • ‹ Back
          • Procurement Transformation ›
            • Procurement Transformation
            • ‹ Back
              • Procurement Strategy
              • Org. Design & Implementation
              • Capability Building
              • Change Management
              • Governance & Performance
              • Processes & Policies
              • S2P Operations
              • Sourcing & Category Management
              • Technology
          • Digital Procurement Transformation
          • Opportunity Assessment
          • M&A Services ›
            • M&A Services
            • ‹ Back
              • M&A Clean Room
          • Strategic Cost Management ›
            • Strategic Cost Management
            • ‹ Back
              • Zero-Based Budgeting
          • Supply Chain Risk Management
      • Supply Chain Consulting ›
        • Supply Chain Consulting
        • ‹ Back
          • SUSTAINABILITY AND RESILIENCE
          • Environmental, Social and Governance
          • Socially Responsible Sourcing
          • Scope 3
          • PLAN
          • Digital Planning, S&OP, S&OE
          • Collaborative Planning
          • PROCURE
          • Source To Contract
          • Procure To Pay
          • MAKE
          • Inventory Strategy & Management
          • Operations & Manufacturing Excellence
          • DELIVER
          • Network Strategy & Optimization
          • Warehousing & Transportation Management
  • GEP Software ›
    • GEP Software
    • ‹ Back
      • GEP SMART ›
        • GEP SMART
        • ‹ Back
          • Procurement Software
          • Direct Procurement Software ›
            • Direct Procurement Software
            • ‹ Back
              • Bill of Materials Management
              • Data Analytics & Reporting
              • Inventory Management
              • Master Data Management
              • Quality Management
              • Supplier Collaboration Portal
              • Supply Chain Operations
          • Indirect Procurement Software ›
            • Indirect Procurement Software
            • ‹ Back
              • Source-to-Contract
              • Spend Analysis
              • Savings Project Management
              • Category Management
              • Contract Management
              • Savings Tracking
              • Sourcing
              • Supplier Management
              • Procure-to-Pay
              • Guided Buying
              • Procurement Portal
              • Catalog Management
              • Order Processing
              • Invoice Management
          • Digital Procurement Transformation
          • Master Data Management
          • Product Accessibility
          • AP Automation
          • Spend Management
          • SMART S2P Technology
      • GEP NEXXE ›
        • GEP NEXXE
        • ‹ Back
          • Supply Chain Visibility and Execution ›
            • Supply Chain Visibility and Execution
            • ‹ Back
              • Inventory and Warehouse Management
              • Logistics Visibility
              • Control Tower
          • Supply Chain Planning ›
            • Supply Chain Planning
            • ‹ Back
              • Supply Chain Control Tower
              • Should-Cost Modeling
              • Demand Planning
              • Supply Chain Bill of Materials
              • Supply Chain Direct Sourcing
              • Supply Planning
          • Supply Chain Collaboration ›
            • Supply Chain Collaboration
            • ‹ Back
              • Forecast Collaboration
              • Purchase Order Collaboration
              • Quality Collaboration
              • Capacity Collaboration
              • Quality Management Software
          • Supply Chain Control Tower
          • Should-Cost Modeling
          • Inventory and Warehouse Management
      • GEP CLICK
      • GEP MINERVA
      • Innovation ›
        • Innovation
        • ‹ Back
          • Emerging Technologies
          • Native to Cloud
          • Native to Mobile
          • One Unified Platform
          • Security
          • User-Centric Design
  • GEP Managed Services ›
    • GEP Managed Services
    • ‹ Back
      • Procurement Outsourcing ›
        • Procurement Outsourcing
        • ‹ Back
          • Source-to-Contract
          • Spend Analysis
          • Strategic Sourcing ›
            • Strategic Sourcing
            • ‹ Back
              • MRO
              • CAPEX
              • Logistics
              • Packaging
              • IT & Telecom
              • Energy
              • Direct Materials
          • Category Management ›
            • Category Management
            • ‹ Back
              • Contract Management
              • Supplier Performance Management
              • Savings & Compliance Tracking
          • Supply Market Intelligence
          • Tail-Spend Management
          • Procurement Support Services ›
            • Procurement Support Services
            • ‹ Back
              • eSourcing
              • Supplier Performance Management
              • Savings & Compliance Tracking
              • Sourcing Support
          • Procure-to-Pay
          • Cost Recovery & Invoice Auditing
          • Accounts Payable
      • Supply Chain Outsourcing ›
        • Supply Chain Outsourcing
        • ‹ Back
          • Planning & Forecasting
          • Inventory Management
          • Logistics Management
          • Supply Chain Data Management
          • Supply Risk Management
  • Industries ›
    • Industries
    • ‹ Back
      • Automotive
      • Chemicals
      • Consumer Packaged Goods
      • Energy & Utilities
      • Financial Services
      • Government & Nonprofit
      • Industrial Manufacturing
      • Life Sciences
      • Oil & Gas
      • Retail
      • Telecommunications, Media & Technology
      • High-Tech
      • Media & Entertainment
      • Software, Social & Platforms
      • Telecom
      • Travel & Hospitality
  • Knowledge Bank ›
    • Knowledge Bank
    • ‹ Back
      • Digital Transformation
      • Operations
      • Procurement
      • Software & Technology
      • Strategy & Planning
      • Sustainability
      • Podcasts
      • Insights from the Top
      • COVID-19 Resource Center
      • Inflation Strategies
  • Company ›
    • Company
    • ‹ Back
      • Leadership
      • Customers
      • Partners
      • Sustainability at GEP
      • News
      • Events
      • Culture ›
        • Culture
        • ‹ Back
          • GEP Core Values
          • Women@GEP
          • Diversity
          • GEP Cares
      • Mission & Vision
      • Awards & Recognition
      • Contact Us
  • Global Presence ›
    • Global Presence
    • ‹ Back
      • Americas ›
        • Americas
        • ‹ Back
          • English
          • Español
          • Portugués
      • Europe ›
        • Europe
        • ‹ Back
          • English
          • Deutsch
      • Asia-Pacific ›
        • Asia-Pacific
        • ‹ Back
          • English
          • 中文
      • Middle East ›
        • Middle East
        • ‹ Back
          • English
          • العربية
  • Contact Us
  • Careers ›
    • Careers
    • ‹ Back
      • Join Us
      • GEP Per Se
      • Campus Connect
  • Language ›
    • Language
    • ‹ Back
      • English
      • Français
      • Español
      • Deutsch
      • Português
      • 简体中文
      • 日本語
  • Rapid Response from GEP
  • BLOGS
  • Strategy
  • Technology
  • MIND
Contact Us
  •  
  •  
  •  
  •  
  •  
  •  
  •  

Breadcrumb

  1. HOME
  2. BLOG
  3. MIND
  4. KEY TRENDS IN THE REGULATORY OUTSOURCING SERVICES MARKET
Blog Image

Key Trends in the Regulatory Outsourcing Services Market

May 09, 2019 | Pharma and Life Sciences Blogs

The regulatory services outsourcing market is expanding at a rapid pace, thanks majorly to biotechnology and pharma companies. With an increase in the drug pipeline, product registration, application of clinical trials and R&D activities, among other factors, such companies are under constant pressure to obtain timely marketing / clinical approvals from regulators in the different regions they operate. For this, they need to meet many complex regulatory requirements that involve submitting huge volumes of documents to regulatory bodies for approval. Any errors in submission or any missed deadlines can prove costly. This involves many time-consuming activities and is not always easy to manage in-house.    

Outsourcing such regulatory services has proved to be a highly effective strategy for many pharma and biotech companies — not only does it leave them free to focus on their key areas, it also helps them improve their overall efficiency and optimize costs. The global regulatory services outsourcing market is expected to contribute more than $5 billion by 2023, growing at 11 percent between 2015 and 2023. Submission planning and publishing, medical writing, writing of regulatory documents, etc. have been the major growth drivers for this market.

Outsourcing Trends

Although most of the biotech and pharma companies outsource their regulatory services, the outsourcing trend differs based on the size of the company.

Large pharma companies usually outsource about 50 percent of their regulatory affair services. These organizations have the necessary infrastructure, expertise and FDA submissions. They have an extensive portfolio and pipeline of products, so having an in-house regulatory affairs department is feasible. They deploy vendors primarily to address capacity issues or supplement their internal capabilities. Outsourcing also helps them reduce expenses, achieve scalability and utilize technological support from vendors.

Mid-sized pharma companies outsource about 75 percent of their regulatory requirements. Athough they do have an in-house regulatory affairs department, they mostly outsource their pharmacovigilance and other regulatory requirements. Such companies often face resource and technology shortages, so they tend to integrate with suppliers on a project basis. They generally outsource the management of applications and submissions to consultants.

Small biotech and pharma companies outsource more than 90 percent of their regulatory solutions. They usually lack the necessary expertise, time and money, and prefer to outsource end-to-end services. These companies usually focus on research, product development and marketing.

Outsourcing Models

Regulatory requirements, challenges and concerns vary based on the type and size of the company. There are three major models emerging in the regulatory outsourcing market: the functional service provider (FSP) model, the end-to-end service model and the hybrid model.

The FSP model is preferred by pharma and biotech giants, as they offer increased flexibility and efficiency without further addition to costs. This model enables companies to pick and choose services as per their requirements — they do not need to select the entire package. The FSP model has gained importance in regulatory outsourcing in recent times due to its ability to provide unique solutions.

The end-to-end services model is usually favoured by small biotech and pharma firms. Vendors offering this model need to have technical expertise in drug development and should be able to support the biotech or pharma firm throughout a product’s development. They assist in preparation, filing and management of all documents, and provide regulatory services for product development, management of global submissions, authority liaison, etc.

The hybrid model is well suited to the needs of mid-sized companies. Here, vendors act as FSPs for the domestic market and end-to-end providers for international markets.

Supplier Landscape

Pharma and biotech companies partner with contract research organizations (CROs) for their outsourcing needs, and this includes regulatory affairs services. Most companies opt for CROs when it comes to outsourcing their regulatory services. They believe CROs have the conceptual and technological expertise to provide efficient results. There are certain niche providers as well that offer services such as medical writing, translation, publishing or a combination of a few services. These smaller firms are either consulted for smaller assignments, or work in collaboration with smaller CROs.

To evolve into one-stop solution providers, the larger CROs are now acquiring niche or small-sized CROs to scale-up operations and grow their services portfolio. They are also partnering with technology companies to incorporate digital innovation while gathering patient data. The patient data collected in real time through mobile apps or monitoring devices is helping them achieve smoother FDA submissions.

 

Tags: pharma

Add Comment +

FEATURED POST

...
Supply Chain Strategy Blogs

How to Effectively Monitor Scope 3 Emissions From Your Supply Chain

...
Supply Chain Software Blogs

From Cost to Resiliency: How Supply Chain Priorities Have Changed

    BLOG CATEGORIES

  • Marketing Blogs
  • Professional Services Blogs
  • Pharma and Life Sciences Blogs
  • IT & Telecom Blogs
  • Logistics Blogs
  • Chemicals Blogs
  • Energy & Utilities Blogs
  • Market Intelligence Blogs
  • Oil and Gas Blogs
  • MRO Blogs
  • Supply Chain Blogs
  • Facilities Management Blogs
  • Human Resource Blogs
  • Agro Blogs
  • Procurement Process and Excellence Blogs
  • CAPEX Blogs
  • Direct Materials Blogs
  • Packaging Blogs
  • Automotives Blogs
  • Healthcare Blogs
  • Corporate Travel Blogs
  • Metals & Minerals Blogs
  • Technology Blogs
  • Awards and Events Blogs
  • Category Management Blogs

TAGS

sustainability
Procurement Software
supply chain strategy
Inflation
Russia-Ukraine War

By checking the box below, you consent to GEP using your personal information to send you thought leadership content – such as white papers, research reports, case studies – and other communications. GEP representatives may contact you to provide additional information or answer questions.

If at any point in time you decide to withdraw your consent, you may unsubscribe by emailing your request to us at privacy@gep.com.

Please refer to the GEP Privacy Statement to understand how we manage and protect your personal information.

Terms of Use | Privacy Statement

Contact Us

Ask Us

Send us your question(s)

RFP

Request for a business proposal

Feedback

Share your thoughts, comments and suggestions

Demo

Schedule a live demo of our software

Discover
STRATEGY
Strategy
  •   Procurement Consulting
  •   Digital Procurement Transformation
  •   Strategic Cost Management
  •   Opportunity Assessment
  •   Supply Chain Risk Management
  •   Supply Chain Consulting
  •   Supply Chain Strategy
  •   Supply Chain Diagnostics
  •   Inventory Optimization
  •   Procurement Transformation
  •   Sustainability and ESG Consulting
SOFTWARE
Software
  •   Procurement Software
  •   Supply Chain Software
  •   Source-to-Contract
  •   Procure-to-Pay
  •   Supply Chain Planning
  •   Supply Chain Collaboration
  •   Supply Chain Visibility & Execution
  •   Supply Chain Control Tower
  •   Should-Cost Modeling
  •   Inventory & Warehouse Management Software
  •   Source-To-Pay Software
MANAGED SERVICES
Managed Services
  •   Procurement Outsourcing
  •   Strategic Sourcing
  •   Tail-Spend Management
  •   Category Management
  •   Procurement Support Services
  •   Supply Chain Outsourcing
  •   Supply Chain Planning & Forecasting
  •   Inventory Management
  •   Logistics Management
COMPANY
Company
  •   About Us
  •   Leadership
  •   Customers
  •   Sustainability at GEP
  •   Careers
  •   News
  •   Awards
  •   Partners
  •   Contact Us

Fresh Insights, Now on Your Phone

  • Dowmload On The App Store Button
Stay Connected
  •  
  •  
  •  
  •  

Latest Tweets

  • The #SupplyChain and #procurement #software market is in flux amid #MnA. If your software provider gets acquired, w… https://t.co/orQlKUZB4X

  • #SupplyChain #disruptions are a reality in today's unpredictable world. Learn how @gepsoftware has helped #SGS resp… https://t.co/jA2GnbWIBg

  • What steps can companies take to achieve #ESG goals effectively? Well, they can start with #procurement. Learn how… https://t.co/HGEfNyGdeD

  • #ElectricVehicles are a key part of the auto industry's plan to become #NetZero by 2050. But EVs aren't enough on t… https://t.co/YlEoys6vTA

  • Why did Asahi choose #GEP as their #procurement and #SupplyChain partner? Check out this video featuring Carmen Rad… https://t.co/RmstcfJXtm

  • GEPpers know how to have a good time! Check out a glimpse of our Winter Party at the GEP Prague office. We are hir… https://t.co/BqVK6XkpHv

  • #Inflation has dampened expectations for GDP growth and raised the risks of a #recession. What can #procurement lea… https://t.co/Hn1R5bxZXn

  • 4D seismic #technology is opening deep-sea #OilAndGas reserves for exploration, lowering costs and optimizing reser… https://t.co/Omq51vlEq7

  • The #GEP Europe Outlook 2023 Roadshow is coming to a city near you! Join us to learn the seven critical priorities… https://t.co/Hzv68et4Rr

  • GEP wishes a Happy Republic Day to all the Indians around the world.  We are #hiring. Explore our careers section:… https://t.co/RKTsyBfQFc

  • Sustainability Outlook for 2023: Trends, Insights and Actions 25 Jan 2023 https://t.co/58KIepy577

  • #Pharma companies are reshoring production, but shortages of active pharmaceutical ingredients make it a challenge.… https://t.co/a3uQJhn7tx

  • With uncertainty looming over 2023, there’s no end in sight to the challenges for #SupplyChain and #Procurement lea… https://t.co/O9tWELnt2i

  • Tight timelines and #COVID-related uncertainties made post-merger data ecosystem #convergence a tricky task for thi… https://t.co/RY6du0AP1D

  • Discover the keys to operating a strategic #procurement and supply function at an essential #PetroChemicals company… https://t.co/sJZmqhnWvS

  • What action should business leaders be taking on #sustainability in 2023? Join #GEP Founder and COO @JT_Turimella a… https://t.co/aerbJSp3GU

  • The pandemic and a labor shortage have exposed gaps in #pharma supply chains. Digital #SupplyChain transformation c… https://t.co/Bwvey5ObWn

  • GEP wishes everyone a very Happy Lunar New Year. May this Year of the Rabbit herald fresh starts and renewal of pro… https://t.co/Lnf3ZkO2zJ

  • Facing uncertainty and #disruption, #procurement needs agility — something #ERPs can’t provide. Here are 5 things t… https://t.co/ouGnhfW6wM

© Copyright GEP 2022. All rights reserved. Terms of Use | Privacy Statement | Cookie Policy |   | Quality Policy | GEP Logo