IMG 2018 Veeva Banners RegulatoryOne

    The Ultimate Guide to
    Regulatory Management

    What is Regulatory Management?

    Regulatory Management, or Regulatory Compliance, is a set of policies, processes, controls and tools employed by an organization to comply with local and/or global regulatory policies, laws and standards.

    Every country has its own unique regulatory system to make laws, regulations and rules, as well as a set of procedures for implementing them. In recent years, companies are experiencing heightened scrutiny and restrictions across key markets like China and the EU. Just last year, China announced the establishment of the State Administration for Market Regulatory (SAMR), which covers cosmetics, food and pharmaceutical industries.

    In other industry categories, regulations have been stagnant for years, even decades. As new trends and scientific and technological advancements progress, the regulatory landscape will continue to change faster than ever before. The modernization of these regulations has the potential to be very disruptive to regulatory departments. Especially considering regulatory teams are rarely granted new resources or tools to handle the increased workload.

    These new regulations mean that it's harder than ever for companies to get their products into the market with speed, while remaining compliant with each country’s regulations.

    Regulatory Management Software helps businesses coordinate these complex regulatory and compliance activities and improve the efficiency of its processes. It also helps to proactively address the risks relevant to an organization. All facets of your business, including marketing, sales, R&D and operations, must be a part of your Regulatory Management process.

    Regulatory Modernization

    What is Regulatory Management Software?

    For industries subject to strict regulatory requirements, such as Chemical, Consumer Goods and Cosmetics, Regulatory Compliance Management Software is an invaluable solution for managing internal, external, local and/or global regulatory requirements.

    Bringing compliant products to market has never been more complex. Compounding an ever-changing regulatory landscape is the fact that most companies still struggle with poor data quality, duplication, and limited visibility into regulatory activities because of disjointed processes. Reducing and managing this complexity is a critical step in satisfying compliance requirements globally and accelerating a product’s time to market.

    What does compliance software do?

    Compliance & Regulatory Management Software provides a global authoritative source for regulatory documents and information. Content and data converge on a single platform to unify registration tracking, correspondence and commitments, submission document management, dossier publishing, and regulatory submissions archiving.

    Establishing a single source for regulatory information dramatically increases efficiency. Data and documents are entered just once and are accessible in any context. This approach minimizes discrepancies and uncontrolled copies, ensuring your information is accurate, timely, and easily found. Organizations can respond faster to product and regulatory changes or compliance concerns.

    Why is Regulatory Management Software Important?

    In today’s regulatory environment, Regulatory Management Software is virtually mandatory. Here’s why:
    1. Reduced Compliance Risk

      On top of being effective, the products your company creates must be compliant with numerous levels of regulations before entering each unique market. Compliance is an especially challenging task because regulatory bodies are constantly introducing new regulations and refining existing ones.

      No business ever wants to pay out millions or even billions of dollars in fines and legal fees. Not to mention the negative media attention and brand perception costs that come from regulatory and compliance investigations.

      With a Regulatory Management Software System, all the information you’ll need for an audit will be automatically tracked and easily accessed. Moreover, you can set up notifications alerting you to discrepancies in near real-time, enabling you to run internal audits anytime on demand.

    2. Efficiency

      A well-implemented Regulatory Management Software Solution minimizes the time and money you spend on regulatory compliance. From allowing you to quickly locate documentation, to proactively accessing the impact of a proposed product or formulation change, Regulatory Management Software allows organizations to stay agile and responsive in meeting complex and changing global regulations.

      It also allows you and your employees to be familiar with the legal framework in which the business operates, ensuring that all facets of your business remain compliant with global regulations.

    3. Increased Quality

      Regulations and laws exist to ensure that businesses operate at certain standards, including safety and quality. So embrace them! Regulatory Management Software not only allows organizations to meet global laws and regulations, it also allows them to meet customer expectations, run effectively and efficiently, lower costs and reduce waste.

    4. Build Consumer Trust

      Over the past decade, influenced by the onset of social media, the consumer’s perception of a brand has become increasingly relevant to manufacturers. Meeting customer expectations is vital to the success of a business. By committing to meeting regulations and global guidelines, a company shows its customers that it takes their safety and satisfaction seriously. This builds customer trust and brand loyalty.

    5. Speed to Market

      Today’s market forces demand that companies stay agile and responsive to meet customer expectations. Well-implemented Regulatory Management Software allows you to quickly assess the impact of a proposed product or formulation change, locate the substantiating and source documentation and coordinate activities on a global, regional and local basis.

    6. Reliable Data Quality

      Regulatory Management Software ensures data integrity as you coordinate product release processes across your stakeholders. Regulatory Management Solutions allow you to Capture timely and accurate information for your product portfolio in a single source of truth that can be accessed globally. 

    7. Global Coordination & Alignment

      The current regulatory environment demands that your company is able to orchestrate compliance-related activities across manufacturing sites, supply chains, outsourced manufacturers and all internal stakeholders. Regulatory Management Software allows you to keep a record of accurate product information that is timely and accessible throughout the entire product lifecycle.

    Regulatory One

    Regulatory Management Software Solutions

    From product registration and submission to publishing and archiving, Regulatory Management can become tedious and time-consuming. Keeping track of all compliance documents, tracking all activities and communicating between multiple departments can cost your business time and money in employee hours.

    Bespoke, manual systems are no longer fit to meet the growing compliance and regulatory needs. In order to be agile in responding to changing regulations, businesses today are switching to Regulatory Management Software Solutions that provide a centralized means of managing and tracking their regulatory management processes. These efficiency gains improve your time to market, while providing transparency across your entire organization with each product release gate that a product passes through on its way to market. 

    Cloud-Based Solutions

    Innovation in the quality and regulatory sector has been stagnant for two decades, leaving businesses struggling against manual and cumbersome on-premise Quality and Regulatory "solutions".

    While on-premise software was at one time the latest technology, it is increasingly being replaced by cloud-based solutions across industries and business units. Gartner says more than $1 trillion in IT spending “will be directly or indirectly affected by the shift to cloud” by 2020.

    Multi-tenancy is the defining attribute of a pure cloud software. It enables the secure deployment of only one version of cloud software to all customers and allows for quick, ongoing innovation that minimizes IT burden. In contrast, hosted systems require vendors to maintain multiple versions of their software, resulting in a substandard product with infrequent upgrades that are time-consuming for customers to implement.

    Better control, visibility, and partner collaboration are just a few of the other benefits that may motivate your company to start looking for cloud-based software.

    Elements and Qualities of Regulatory Management Software

    A good Regulatory Management Software Solution is cloud-based and coordinates all facets of the regulatory process, providing you with visibility into what you’re selling, when you can sell it, and where it’s being sold.

    Regulatory Management Software allows you to coordinate activities on a global, regional and local level, ensures data integrity and has the following capabilities:

    1. Centralized Processes

      Access all assets related to your product — from ideation, to testing, to branding and manufacturing, all the way to post-purchase support — in one secure place.

      By investing in unified cloud-based software for managing processes and data, you can streamline your process in the following ways:

      • Advance all relevant content together — through auditable, secure digital processes that make it easy to collaborate across departments and with outside partners
      • Track content requirements for each region, and quickly identify the most recent content versions from each team
      • Access a global dashboard showing the real-time status of active projects
      • Work the way and at the pace you do in the other areas of your life
    2. Unified and Cloud-based

      The cloud-based (or multi-tenant) software delivery method has become the software industry’s preferred delivery method — with good reason. Maintaining only one version of code allows cloud software vendors to innovate faster and provide more value to all their customers with every investment.

      Unified cloud-based software helps centralize your process, setting your teams up to work more efficiently to target and focus on your top business priorities.

    3. Data Consolidation

      Finding the latest, approved version of your brand’s content should be as easy as doing a quick digital search.

      With unified cloud-based software, you’ll no longer have to dig through your email inbox to find what you hope is the latest version of product claims, registration records, or package designs. Instead, you and your teams will share a common resource for managing regulatory, brand, and quality processes and content.

      This minimizes discrepancies and uncontrolled copies, ensuring your information is accurate, timely, and accessible — empowering your teams to respond faster and with more confidence to product changes, compliance concerns, claims management, or regulatory authority requests.

    4. Streamlined Regulatory Inspections

      What if we told you that an audit could proceed just like any other day?

      With unified cloud-based software, all the information you’ll need for an audit will be automatically tracked and easily accessed. Moreover, you can set up notifications alerting you to discrepancies in near real-time, enabling you to run internal audits anytime on demand.

      When everything is recorded in a single system, you can easily show an auditor how you normally work and how you access any type of information with just a few clicks.

    Tech person touching button with orange light beams concept

    Critical Capabilities of Regulatory Management Software

    Registrations - Manage product registration information globally and provide access to internal and external parties at any time. View your product data by registration status, by market, by variation and maintain communication with regulatory bodies.

    Submissions - Plan, collect, review and approve all product related content including submission-ready documents, content planning and tracking, correspondence, product claims commitments and submission records. The submissions capabilities of your Regulatory Management Software should provide you with full traceability for all your regulatory activities.

    Submission Publishing - Ensure your final product submission is seamless with your Regulatory Management Software Solution. A continuous publishing process provides greater visibility and speed throughout the product release process and allows you to more dynamically respond to changing regulations across the markets you serve.

    Submission Archiving - Access all of your product submission components for authorized internal and external stakeholders to both use and reuse in local markets.

    Product Claims Management and Regulatory Compliance

    Another large piece of Regulatory Compliance Management is Product Claims Management. Marketing and product claims are critically important to companies, helping to define functional product benefits, differentiate from competition, and support the brand. The process of developing claims, substantiating, and monitoring usage is complex, involves multiple stakeholders, and can involve significant regulatory and legal risk for companies. 

    In today’s environment of heightened awareness around the use of claims by regulatory bodies, consumer groups, and competitors, it has never been more important to maintain control of the claims process.

    In conjunction with Regulatory Management solutions, Claims Management software should help your company:

    Reduce Risk by maintaining a complete view of your claims and allow you to respond to issues or challenges efficiently. Features may include: auditable workflows, direct links to substantiation documentation and downstream claim utilization in assets, and a library providing a single source for claims.

    Improve Speed to Market by enabling rapid development of new claims for product launches and reduced rework during legal and regulatory reviews. Features my include: custom built workflows, dashboards and metrics around the claims process, and a single location to store the latest approved claims for all your products 

    Build Stronger Brand Stewardship by reducing the probability of unapproved claim use, responding to challenges quickly and confidently, and protecting the reputation of your brand. Claims Management Software allows you to bring greater clarity and control to the process of managing product and marketing claims throughout your organization.  

    Ready to explore how Veeva can help you transform your organization? 

    Try Veeva Watch Demo Read Product Brief