Regulatory Operations & Regulatory Affairs: The Air Traffic Control Tower of Life Sciences

Just as we need experienced air traffic control specialists to ensure safe airplane travels, life sciences companies need experts who can navigate the inherent complexities of interactions with regulatory authorities who authenticate the safety of products on the market. Enter regulatory operations professionals, whose essential coordination roles involve constant communication, both externally with regulators and internally with the personnel in their organizations whose work affects regulatory applications. A better understanding of regulatory operations professionals’ objectives and needs provides insight into the tremendous impact they have on regulated product developers’ successes or failures.

What Is Regulatory Operations?

Regulatory operations professionals coordinate the essential documentation and resources required for the filing of global applications. For pharmaceutical/biotech organizations, such submissions include:

• New drug applications (NDAs).
• Investigational new drug applications (INDs).
• Biologics license applications (BLAs).
• Marketing authorisation application (MAAs).

For medical device organizations, this includes:

• Premarket approval applications (PMAs).
• 510(k) premarket notifications.

Those outside of regulatory departments often believe the management of regulatory documents is a straightforward process because they tend to assume all documents used in regulatory submissions are approved long before they make it into the final submission. Yet nothing could be further from the truth. All content generated by the functional groups that contribute to regulatory submissions — areas as diverse as pharmacology, manufacturing, clinical, and marketing — must make its way through regulatory operations so that it can be appropriately submitted to the designated agency for a particular product in order for the product to gain approval. The sheer quantity of new and revised documents that regulatory operations must manage is overwhelming and can quickly get out of hand. Not only do documents come from myriad functional areas, they are also multiplied by other factors that add to the complexity of submissions management, such as:

• Product line.
• Indication.
• Regulating agency or agencies.
• Country.

In addition, many submissions require certain forms to be provided in duplicate or triplicate. And many of the documents included in submissions also entail strict reporting requirements (i.e., safety reports, annual reports, periodic safety updates, etc.), which further amplifies the importance of proper coordination and transparency. In regulatory operations, the connectivity of and visibility into documents and data is paramount.

The Difference Between Regulatory Operations and Regulatory Affairs

Although the terms are commonly used interchangeably, there is often an implied distinction in life sciences settings that regulatory operations pertains to the internal processes and activities associated with keeping a regulatory submission on track while regulatory affairs is an overarching term pertaining to all aspects of regulatory compliance and the corresponding interactions with regulators that are required throughout submissions processes.

The Regulatory Affairs Professionals Society (RAPS) defines regulatory affairs as “a profession within regulated industry whose members are responsible for ensuring their companies comply with all applicable laws and regulations; working with local, regional and national regulatory authorities and personnel on issues affecting their businesses; and advising their companies on regulatory aspects that could impact their business.” ⁽¹⁾

The regulatory operations function is concerned with the logistical and administrative side of maintaining the compliance and timeliness of submissions. Regulatory operations professionals must not only manage versions and revisions of standalone documents but must also know where and when those documents were submitted to regulatory agencies for various applications. They can’t succeed without a reliable document management system.

Document Management Excellence: The Driver of Regulatory Success

The importance of document management in regulatory operations cannot be overstated and is perhaps best illustrated by an example of a typical regulatory document like a clinical study report (CSR). A CSR usually travels along a regulatory pathway such as the following:

• Phase 1: Positive results prove that the investigational product is safe and effective, at which point the CSR is finalized.
• Phase 2: The organization is ready to begin filing marketing applications globally for the approval of the product.
• Phase 3: This CSR is submitted to various regulatory authorities, often in dozens of countries — perhaps for one or more different indications — over a multi-year period.
• Phase 4: As different regulatory agencies are reviewing the CSR during this period, there may be questions or requests for clarification on data that may trigger the need for revisions of the original CSR, resulting in the submission of new versions of the document.
• Phase 5: Regulatory operations professionals are tasked with identifying where the CSR has been submitted, what impact the changes will have on the various applications, and whether resubmissions are required.

While the implementation of the electronic common technical document (eCTD) format as the standard for pharma/biotech companies’ regulatory submissions has dramatically improved regulatory operations professionals’ ability to manage an application’s life cycle, it doesn’t address the “where was this document used?” question that they so urgently need to know. Regulatory operations professionals’ roles demand diligence and precision. That’s why it’s imperative to equip them with tools that enable them to maintain faultless document management and give them the exact information they need, precisely when it is needed.

What To Look For in Regulatory Operations Software Solutions

Life sciences companies wishing to stay competitive and accelerate market access must empower their regulatory operations personnel with digital tools that harmonize and simplify global submissions processes. Before implementing a new software that digitizes processes critical to their regulatory affairs, biotech, pharma, and device companies should first ensure that the solution will:

• Automate the collection and management of regulatory content and data. (For medical device regulatory operations, for instance, this includes documentation like design concepts, prototypes, and design and technical files.)
• Provide continuous monitoring and updates from start to finish of every application and registration project.
• Integrate submission planning with full document life cycle management (which vastly improves workflow efficiency).
• Streamline the compilation, routing, review, and approval of regulatory content.
• Centralize content and data within a common platform that provides an up-to-date single source of truth that all stakeholders can access, regardless of their geographic location.
• Simplify and accelerate the search for and retrieval of documents.
• Harmonize regulatory and quality processes (which results in increased productivity and better collaboration).
• Enable authorized users to collaborate in real time.
• Provide a centralized repository for all correspondence with regulators.
• Include an evergreen database of technical documents that will facilitate rapid responses to compliance issues.

Learn More About Managing Regulatory Information

To explore the many ways regulatory operations software can accelerate your global applications and registrations processes and help your products reach more markets sooner, visit MasterControl’s Regulatory Information Management Solutions page.

References:

1. RAPS Regipedia, updated Oct. 4, 2019.