FDA Compliance: Keys to a Robust Regulatory Strategy

March 2025

In the life sciences industry, mistakes are inevitable. Even the most established companies face FDA citations, deviations, and quality issues. The key difference between the companies that persevere and those that struggle is not about the mistakes made, but how they respond, correct, and prevent recurrence.  

The FDA’s Real Focus 

When you look at the most common reasons why pharmaceutical and medical device companies have received citations over the past 15 years, the prevailing theme is issues with procedures. Most companies are cited for either not having proper procedures to deal with quality issues, or not properly following the procedures they do have in place.  

Regulatory bodies do not expect a flawless system, but they do expect the ability to identify root causes, take proper corrective actions, and cultivate continuous improvement.  

Most Common Topics Found in 483 Citations 

A poorly structured and/or executed regulatory strategy can lead to costly remediations, reputational damages, and worst-case, operational interruptions. While the FDA inspects many aspects of a quality system, there are some key areas companies can focus on to ensure they have a well-managed strategy and execution: 

1. Clear Root Cause Analysis on Investigations: Did you properly investigate and understand why an issue occurred? 

2. Corrective & Preventive Actions (CAPA): Have you taken steps to fix the problem and prevent it from happening again? 

3. Procedures & Documentation: Can you provide clear records of your procedures and documented evidence that you’re following them? 

The FDA isn’t focused on perfection—they want to see how you fix and prevent problems. They are looking for continuous improvement and if your team prioritizes compliance and quality, or if you just react to quality system failures. 

Gaining a Competitive Advantage  

Today’s regulatory landscape is evolving faster than ever, and companies who treat quality and compliance as a strategic opportunity rather than an obstacle are gaining an edge over competitors.  

A strategic and proactive approach goes well beyond maintaining compliance, it reduces operational costs and opens opportunities for improving the bottom line and actively contributing to an organization’s success. This looks like real-time documentation, preventive detection, and constant visibility into the performance of quality systems.  

At OQSIE, we partner with life science leaders to build resilient quality systems that go beyond meeting compliance—they drive business success. Is your organization prepared for its next FDA audit and ready to take compliance to the next level? Let’s discuss how we can help. 

Key Industry Trends To Watch Out for in 2025

December 2024

As the life sciences industry continues to advance, there are some trends gaining momentum that operational leaders should prepare for as 2024 comes to a close.

Here are three trends to watch out for in the life sciences industry in 2025:

1. Increase Use of Artificial Intelligence (AI) in Operations

AI has been a trending topic for some time now, and while most organizations have been focused on applying this technology in the research and development (R&D) space, few are just scratching the surface in operations.

When it comes to Generative AI, McKinsey’s research suggests that the potential opportunity for the pharmaceutical operations value chain is $4 billion to $7 billion.¹ This technology is expected to reduce supply chain and quality costs and increase overall productivity across all operational functions.

In the next year, AI will continue to make strides across functional areas and will especially gain momentum in supply chain and manufacturing organizations. A recent report by Arnold & Porter found that 62% of life sciences senior executives are actively using or plan on using AI in manufacturing.²

LogiPharma’s recent report, where they surveyed 100 European supply chain leaders, also found that 40% of companies are prioritizing AI for demand forecasting and minimizing waste.³

Those companies who are currently leveraging AI and experiencing the benefits in other areas will carry that momentum into their manufacturing, supply chain, and quality organizations over the next year.

2. Evolving Regulatory Environment 

As the industry continues to evolve with real-time data, personalized medicines, and other advancements, so will the regulatory environment.

To keep up with the industry progression, regulatory bodies such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have been working on adaptive regulatory pathways for advanced therapies and scientific innovations.⁴

The industry is also expecting global regulatory harmonization efforts to continue as more agencies across the world increasingly adopt the International Council for Harmonisation’s (ICH) guidelines.⁴

You can read more about these emerging regulatory trends here.

3. High Demand for Digital Skills

It should come to no surprise that the demand for digital skills will keep increasing across entire organizations as more companies continue digitizing and implementing advanced technology.

Deloitte’s data shows that the demand for digital roles in the life sciences industry has significantly increased over the last five years. Since 2019, job postings for data engineers have increased by 69% and 16% for data scientists.⁵

When it comes to supply chain, 83% of leaders acknowledge the need to upskill or reskill a significant portion of their supply chain workforce to support digital transformation, according to Deloitte’s survey.⁵

Their survey also found that the top three roles most needed are data scientists and engineers, functional experts, and AI specialists.⁵ 

Operational leaders can expect heightened competition in the next year to access professionals with both functional and digital skills to support their transformation initiatives.  

The industry is advancing rapidly and to stay competitive, leaders must prepare their organizations to embrace advanced technology, create strategic partnerships to stay on top of ever-changing regulations, and prioritize talent development and the acquisition of niche digital skills.

Those who focus on leveraging these trends can position their organizations to lead in efficiency and performance within a competitive and dynamic landscape.  

Want to ensure your organization is prepared to overcome challenges in 2025? Submit a request for a discovery call to talk about how OQSIE can help your team ensure efficiency and effectiveness.

Sources:

1. McKinsey & Company’s “Generative AI in the pharmaceutical industry: Moving from hype to reality”
2. Arnold & Porter’s “AI is Transforming Life Sciences but Raising Risk Concerns, New Benchmark Report Finds”
3. European Pharmaceutical Manufacturer’s “AI: A strategic imperative for pharmaceutical supply chains”
4. Life Sciences Review’s “Global Harmonization And Emerging Trends In Life Sciences Regulation”
5. Deloitte’s “To digitize its supply chain, biopharma may first need to close a workforce skills gap”

The FDA’s Five Areas of Consideration for AI in Drug Manufacturing

September 2024

Artificial Intelligence (AI) has been a topic of conversation in the life sciences industry for years now. While some have made progress adopting this technology, most are beginning to explore the possibilities it offers across the value chain, and just scratching the surface on the opportunities it holds for drug manufacturing.  

As it transforms the manufacturing space, the FDA has been evaluating different use cases and how to regulate it in efforts to help inform the existing regulatory framework. In 2023, the Agency published a discussion paper which dove deeper into the uses and potential risks of AI in drug manufacturing, as part of the Framework for Regulatory Advanced Manufacturing Evaluation (FRAME) Initiative.  

In addition to providing some potential applications of AI in pharmaceutical manufacturing, the FDA also presented some areas of consideration they were seeking feedback on. These areas focused on the manufacture of drug products that would be marketed under a New Drug Application (NDA), Abbreviated New Drug Application (ANDA), or Biologics License Application (BLA).  

The FDA’s Artificial Intelligence in Drug Manufacturing paper lists the following five areas of consideration associated with AI:  

1. “Cloud applications may affect oversight of pharmaceutical manufacturing data and records. 

2. The IOT [Internet of Things] may increase the amount of data generated during pharmaceutical manufacturing, affecting existing data management practices. 

3. Applicants may need clarity about whether and how the application of AI in pharmaceutical manufacturing is subject to regulatory oversight. 

4. Applicants may need standards for developing and validating AI models used for process control and to support release testing. 

5. Continuously learning AI systems that adapt to real-time data may challenge regulatory assessment and oversight.” 

All in all, these areas of consideration pointed to some key themes the FDA is evaluating; ensuring data integrity and quality, managing the potential influx of data, identifying which applications will require regulatory oversight, AI model development and validation, and managing expectations for continuous AI learning systems.  

The discussion paper also highlights some potential associated requirements and policies. You can read the FDA’s Artificial Intelligence in Drug Manufacturing discussion paper here.  

Sources:

U.S. FDA’s Center for Drug Evaluation and Research “Artificial Intelligence in Drug Manufacturing” Discussion Paper

FDA Voices: FDA releases papers on AI and Machine Learning in drug development and manufacturing