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Should Small Pharma and Biotech Companies Build Regulatory Operations Capabilities?


Small pharmaceutical and biotech companies that are preparing to submit their first Investigational New Drug Application (IND) must make decisions about how they will support the production of the initial submission as well as the ongoing management of maintenance submissions. The decision to build capabilities or partner with a Regulatory Submission Management Partner (RSMP) is typically based on company and project goals, product pipeline, internal resources, and budget constraints.


Early-Stage Companies Face Many Challenges

Small pharma and biotech companies face several challenges when it comes to regulatory operations. For example, these companies may not have the necessary people or skills on staff or the time to devote to this function. They also might not have the technology in place that larger pharma companies would be able to afford. And their need for financial and personnel resources can change quickly based on research results within their product pipelines. In response, some small pharma companies are deciding to outsource regulatory operations functions while others are building capabilities internally. Each case varies but it’s important to think through critical questions when making this decision.


Expertise Required for Regulatory Operations

The demand for skilled regulatory operations professionals is high. There are few people with the skills and experience required to fill regulatory operations positions because regulatory operations professionals will need a diverse skill set that includes technical, regulatory, and project management expertise. Acquiring this expertise is expensive and may fall beyond the budget constraints of a small organization.

Regulatory Operations (also known as Reg Ops or RO) is a complex function that requires specialized knowledge and expertise. It is important for small pharma companies to understand the regulatory requirements for their drug and determine what resources are needed to meet those requirements. A Reg Ops team (or individual) must understand and monitor relevant regulations, guidances, data standards, and electronic submission standards such as the electronic Common Technical Document (eCTD). Changes in any of these areas can require process or technology changes so the team should be able to assess the changes and understand their implications.

Monitoring changes in regulations and requirements can be time-consuming while understanding how changes impact your operations may require an experienced person to analyze and assess the impact.


Technologies used in regulatory operations include document management, regulatory information management, and submission publishing tools so team members must understand how these tools fit into their processes, how and if they are integrated, and how best to use them to produce, manage and review submission content. It also helps to understand the health authority processes for accepting and reviewing submission content.


When outsourcing regulatory services, it is important to choose a partner that has both a strong track record of accomplishment and strong knowledge of the submission process. Considerations include the number and types of successful submission projects, robust training programs for staff responsible for regulatory operations, and technological expertise.


Optimized Processes

A reliable Regulatory operations function needs documented and compliant processes that are optimized to handle the influx of submissions and still maintain high quality. It's critical that Reg Ops departments have the right people in place with the right training and experience to develop efficient processes that are also agile enough to address last-minute changes that can impact the final submission.


Compliant submission output requires strong quality control principles to be woven into the process. Well-documented procedures are essential, especially as the organization’s needs change. The investment in a quality management program provides a strong foundation for any future capabilities.


When considering outsourcing, it is important to confirm that the regulatory submission partner has these same well-documented, compliant processes that result in quality submission deliverables.

Enabling Technologies for Regulatory Submission Management

Technology can be expensive to acquire and even more expensive to maintain. Regulatory technologies include document management, regulatory information management, and submission compilation and publishing tools. Some teams use a collection of tools to complete their submissions while others use integrated software platforms that enable teams to collaborate and review emerging submission content as well as the final submission. Learning how to use the software tools is just the beginning. Reg Ops teams must ensure their tools produce consistent and reliable output. As new versions of the technology are released, the team must assess risks and benefits, develop strategies to incorporate new functionality into their processes, and update process documentation. As industry requirements change, the team may also need to evaluate new technologies to optimize their practices.


Reg Ops teams need appropriate tools to convert submission files into the appropriate file formats, apply navigation, and apply necessary meta-data according to the eCTD requirements. Submission management tools have matured significantly in recent years. These tools automate large parts of the process. As teams gain experience with the tools, they typically find new ways to apply the technology for greater efficiency and compliance.


The Build vs. Buy Decision

Building the right regulatory operations capabilities can offer small pharma companies many benefits. For instance, building this capability allows the company to have more control over the process and timing of getting their products to market while also making it easier for them to hire and train employees in-house. However, when budgets and timelines are tight, and investments in new resources, technologies, and processes are constrained, outsourcing is a viable option.


Outsourcing regulatory operations can offer the people, processes, and technologies that are not available internally. If you want an internal Reg Ops team but are not ready or don’t have time to build internal capabilities, interim outsourcing can offer a path toward that goal. A good outsourcing strategy can allow your team to gain experience, evaluate and implement technologies, and develop sound processes while still meeting your regulatory submission needs. It also lets your team take a phased approach that considers submission schedules and operational readiness.


Lastly, outsourcing regulatory operations may enable you to focus more on core aspects of your business without the distraction of managing complex and time-consuming processes.


A Final Word

If you outsource regulatory operations, it is important to ensure that all your needs will be met through the contract. Factors such as competency, cost-effectiveness, scalability, and flexibility should be considered when selecting a partner. It is critical to document requirements and expectations before signing any agreement with a vendor. Take time to get to know your partner and the team who will be working on your submission.


If you are interested in finding a submission management partner, contact the WAYS team. We are happy to learn about your submission needs and share our submission experiences.



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