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.
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.
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.
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.
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.
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.