How to Create an Effective Global Regulatory Strategy and Plan

Having and maintaining a strong global regulatory strategy and plans can help your organization not only stay in compliance but can be an integral part of corporate market growth strategies.

How many of us have jumped into a new market before fully understanding the regulatory requirements and the potential impact of those requirements? If you have, you are not alone. Mapping the requirements as part of your strategic planning may help you identify a great new market or help you avoid a costly mistake.

Before delving any further, let us make sure we are all using the terms "regulatory strategy" and "regulatory plan" in a similar way.

• Regulatory Strategy: Aligns the regulatory activities required to bring a new or modified product to market with the business or marketing strategy. It provides overall direction to the team by identifying the important regulatory elements.
• Regulatory Plan: Describes specific steps and action required to meet the regulatory strategy objectives. It contains the specific elements required to assemble the regulatory submissions.

Understand the Benefits of a Global Regulatory Strategy

The benefits of developing and maintaining effective global regulatory strategies and plans are far-reaching. In addition to building a foundation for clear communication within the project team and with management, some of those benefits include:

• Clear definition of the required resources (both human and financial).
• Avoid delays due to new last-minute requirements.
• Improve efficiency.
• Improve accuracy and timeliness of filings.
• Save money because of efficiency improvements and avoidance of delays.
• Help your business stay in compliance.
• Guide corporate marketing strategies.
• Identify a great new market.
• Avoid costly mistakes.

To elaborate on my last point, the planning you do now can help save you from making an expensive mistake. For example, you don’t want to file for a market only to discover you don’t have the required information or learn it may be prohibitively expensive to get the Avoid this and other unnecessary costs by understanding early in the process which resources are necessary compared to the resources you have available.

Include These Elements in Your Global Strategy and Plan

An effective strategy or plan should be aligned with the business/marketing strategy for the product and the company. The strategy or plan must also have cross-functional buy-in from at least regulatory, marketing, product development, and executive management functions and must be feasible with the available internal and/or external resources. It is important to remember that no global strategy or plan should be static. They should be updated as the project progresses or as conditions within the company evolve. 

Your global regulatory strategy should include the following elements: 

• Defines the device or product.
  • Will claims be different or the same across markets?
  • Will device risk be the same or different across markets?
• Defines which markets are of interest preferably with a market analysis to support the viability of the market.
• Type of submission(s) based upon the desired markets.
• Considers life cycle issues that may be applicable.

Elements of an effective global regulatory plan include the following:

• Defines the market specific requirements and how those requirements may be met.
• Defines the submission requirements for each market including timing and any applicable fees.
• Contains specific project deliverables including timing, responsibilities, and resources.
• Defines specific testing that may be required such as preclinical and clinical (note this may be different across markets).
• Defines which standards and/or regulations may be applicable for each potential target market.
• Defines specific country regulatory references.
• Defines appropriate predicate device(s) if the device will be marketed in the US.
• Includes the desired claims for each market (possible claims matrix).
• Includes a plan for how the claims will be supported (labeling, bench testing, engineering rationale, clinical, etc.).
• Contains the specific elements required to assemble the regulatory submission.
• Defines any special requirements such as facility inspection.
• Defines any anticipated post-market surveillance.
• Describes any pre-submission interaction with regulatory agency officials.
• May be a separate document for each potential market or one global plan for all markets.

Define the Roles of Each Function

In order to accomplish cross-functional buy-in and to successfully develop and execute global regulatory plans, it is critical to establish interfaces and to define the roles of each function. All roles are responsible for clear communications across the project team and with management to ensure that any necessary adjustments can be made in a timely way. For example, the roles might look something like this, depending upon your organizational structure:

• Management
  • Provision of resources.
  • Provision of strategic direction.
  • Visibility to reimbursement landscape.
• Quality
  • Product acceptance activities for pre-production and production product.
  • Labeling review and release.
  • Post-market surveillance.
• Regulatory
  • Clinical Evaluation Report (CER).
  • Define the regulatory requirements for all markets.
  • Identify appropriate guidance, regulations, etc.
  • Define predicate(s).
  • Confirm that all claims are adequately supported.
  • Work with marketing and product development to create labeling.
  • Assemble/submit applications.
  • Post-market surveillance.
• Product Development
  • Define the device and its function.
  • Risk analysis.
  • Pre-clinical testing.
  • Clinical Evaluation Report (CER).
  • Provide technical support for applications.
  • Work with regulatory and marketing to create labeling.
  • Intellectual property.
• Clinical
  • Clinical testing.
  • Clinical Evaluation Report (CER).
  • Post-market surveillance.
• Marketing
  • Define the desired claims and provide support for claims if possible.
  • Work with regulatory and product development to create labeling.
  • Provide market analysis to help management determine if market is viable.
  • Trademarks and copyright.
• Regulatory Agency
  • Pre-submission interaction to define any special requirements if applicable.
  • May require post-market surveillance reporting.

Navigate Common Challenges

Now that you know how what elements belong in a global regulatory plan and strategy and understand how important cross-functional collaboration will be to your success, let’s address some common challenges that can arise.

Pressure to Get the Project Started

If you’re under a lot of pressure to get the project started, call a meeting with management and the project team. Remind everyone that investing time up front will save time later. Having adequate time ensures you can start with a draft of a plan and avoid hurried communication, which lead to significant delays.

Scattered Approach

It might be tempting to try and enter every market at the same time. But without a carefully considered plan, you will find there are insufficient resources to do the work and encounter significant time delays. As a result, product may never get cleared/approved or you will be unable to sell the product despite clearance/approval because of intellectual property (IP), reimbursement, trademark issues or other similar issues.

Unforeseen Setbacks

Unforeseen setbacks happen to everyone. Through a well-conceived plan, most setbacks can be avoided or handled quickly. Sometimes setbacks are inevitable, but you can get through them if you remember these three words: communicate, communicate, communicate.

Time and Cost Overruns

A well-conceived plan usually makes it possible to avoid time and cost overruns. When time overruns happen, try and get creative about how to get back on track. Maybe there is a resource that can help in the short term? Even with a plan in place, time and cost overruns sometimes happen, but you can work through them if you remember these three words: communicate, communicate, communicate.

Changes to the Regulations

It’s not uncommon for regulations to change, but you’re usually given a long lead time. It’s important that you stay abreast of regulations that can impact your business by subscribing to news that provides updates and/or subscribe to the FDA website. By staying informed, changes will never catch you off guard.

Difficulty with a Regulatory Agency Reviewer

First, it can always be helpful to establish a professional working relationship with the reviewer that engenders trust. As you work with the reviewer, follow these tips and the process will go as smoothly as possible.

• Be prompt and professional in responding to any inquiries from the reviewer.
• If you are communicating via email, ask for a phone call to resolve any issues.
• If appropriate, ask a physician to interact with the reviewer to address their concerns.
• Make sure you keep accurate records of all interactions with the reviewer.
• Communicate with your project team and management.

At the end of the day, effective execution of global regulatory strategies and plans should save your company time and money and can often help you get product to the markets more efficiently.