Every new product that hits the market, including new pharmaceuticals, must follow regulatory compliance. Regulatory authorities issue guidelines and rules for development, licensing, manufacturing, marketing, labeling, and more. While strict guidelines may seem like a pain, they are highly crucial to pharmaceuticals’ safety and efficacy and their development process. Improved standard methods, efficiency, and costs are a few of the values of growing for regulatory.
The Importance of Regulatory
Regulatory functional groups (commonly known as Regulatory, Regulatory Affairs, Regulatory Operations, Labeling, Lifecycle Management, and RA) are a critical part of the extensive path to a new product launch. They are directly involved in enabling continued access to marketed drug products.
Regulatory groups and processes are crucial to the drug market for several reasons. Regulatory groups and standards are instrumental in speeding up the time it takes a drug to get to the market through innovative regulation strategies and an effective submissions development process. Regulatory also plays a vital role in maintaining patient access to pharmaceuticals and optimizing the developers’ profits through lifecycle management.
The Current State of Regulatory
Due to the benefits of regulatory capabilities, businesses and developers are now focusing on maximizing revenue and minimizing compliance and quality costs, rather than merely focusing on process efficiency.
In recent years, regulatory reporting requirements have shifted from a document-based system to a data-based one. By switching to data-based, new-levels of precision are necessary to execute regulatory responsibilities.
Current Troubles With Regulatory
With the changing landscape of regulatory, some challenges persist that make it difficult for industries, such as drug development, to achieve the regulatory process’s full benefits. The potential consequences of regulatory difficulties include significant increases in costs and a possible reduction in a product’s revenue potential. Here are a few of the current troubles with following regulatory processes.
Regulatory processes touch multiple functional areas, including commercial, R&D, quality, manufacturing, supply chain, and distribution. Many delays in the system can occur as the data filing, approval, and rework can slow the entire regulatory process down or risk possible non-compliance if not followed accurately.
Similarly, each market represents potentially varying requirements and approval processes. This variance makes it difficult to establish a common approach that all markets can follow the same way.
In many instances, regulatory roles and responsibilities are commonly spread across multiple companies throughout a product’s lifecycle. Contracted relationships with suppliers such as CMOs and development partners add layers of governance and regulatory standards that must be followed.
Health Authority Scrutiny
Regulators from different markets are always working together to identify non-compliance and misalignment of information in submissions or other communications. Increasing risk-based inspections, greater scrutiny, and sanctions for non-complying organizations are rising, making following regulations to a tee more critical than ever. If not followed, your business runs the risk of losing money and time spent on the initial process.
Technology and Data Complexity
Regulatory functions have been piecing together, disparate data and systems to achieve marginal capability improvement. In addition to the regulatory system landscape, core processes such as variation management require data transfer from quality, manufacturing, or other systems like marketing. This landscape inhibits the accurate and timely transfer of data and further disruption in cross-functional workflow. In doing so, the efficiency and efficacy of the regulatory process are in jeopardy.
RIM: The Solution To Regulatory Growth
To eliminate the current troubles with regulatory, the RIM model balances cost and regulatory benefits to improve regulatory performance and save businesses vital time and money.
What Is RIM?
RIM stands for regulatory information management. A full set of RIM capabilities across a product lifecycle can further improve the value of growing for regulatory. Here are a few benefits:
Faster Approval Time
A RIM solution connects planning to execution for improved real-time process monitoring. Teams can quickly spot constraints and take corrective action before it’s too late. Also, adopting a common platform can help drive consistency and reduce wasted efforts such as reviewing or editing or needing to validate data brought in from another system. Improved quality translates to fewer health authority questions and commitments during the review process, increasing the likelihood of quick approval.
Optimize Profitability and Access To Drug Products
Integrating RIM with critical processes allows companies to bring products to more markets more efficiently. During lifecycle maintenance, RIM systems also speed the change, control, and variation management process, allowing companies to manage change efficiently and reducing the risk of change-related recalls.
More Efficient Use of Data and Better Planning and Tracking
Process visibility, data quality, and knowing where to find information and documents can significantly increase resource productivity and efficiency. A unified system of metrics can also track process milestones, automatically informing submission plan timelines with actual performance.
Improved Health Authority Interactions
More effective control over a submission via effective use of data and improved planning can lead to a high-quality submission. This results in a more efficient review process for authorities and builds credibility, leading to reduced regulatory burdens.
Operational Oversight and Metrics
A unified RIM solution allows companies to monitor regulatory processes from end-to-end proactively. By collecting detailed and accurate data about the process, performance leads to less detrimental mistakes and more proactive measures to keep the process and the product moving throughout the lifecycle without costly changes.
Compliant Product Release
Prematurely releasing pharmaceutical products before obtaining health authority approval is a common and costly mistake in the industry, especially for companies releasing slight variations of a single product. RIM systems utilize change control and variation monument processes to reduce the likelihood of releasing a variation or updated product into the market before gaining approval from the health authorities.
Regulatory agencies play an integral role in ensuring products released on the market will be safe and effective. Although some common downfalls make following the process a pain for many businesses, the regulatory process has many benefits. Adaption of a RIM or Regulatory Integrated Management System aims to eliminate the downfalls, growing regulatory more cost-effectively and efficiently. Moravek strongly follows all regulatory processes for compliance and safety or pharmaceuticals and custom radiolabeling practices.