The regulatory framework governing medicine development is in flux. Technology innovation, consumer adoption of digital therapeutic interventions and the move towards personalised medicine are some of the factors influencing new regulatory requirements and imposing more stringent quality standards. So, what are the biggest pain points today in regulatory compliance for pharmaceutical manufacturers? How can they be best dealt with?

Sandra Mosquera, director of regulatory affairs at Sofgen Pharmaceuticals, and Alfonso Castañeda, quality manager at Sofgen Pharmaceuticals, answer some of these pressing questions in the Q&A below:

Q: What is shaping the global regulatory landscape for pharmaceutical and nutraceutical manufacturers today?

SM: This is a good question. I think there are three major factors that are – or should be – shaping the regulatory landscape.

#1 Demand for a more efficient approval process.

New drugs can take more than 12 years to reach patients as they navigate complex clinical and approval phases. To reduce timelines as much as possible, drug developers should always involve engage the regulatory authorities early on in the process and keep open communication channels during all development and submission phases so that all stakeholder expectations are satisfied. We also need better international collaboration and harmonisation between regulatory authorities to reduce duplication of efforts and facilitate global drug development and access. We need to strike a balance between implementing more efficient approval processes and maintaining scientific rigor.

#2 Advancements in technology

Personalised medicines, real-world evidence (RWE) data, and lately, artificial intelligence (AI) and machine learning (ML), are advancements that need to be reviewed and framed under a specific regulatory scenario. Sometimes, we can think that scientific advancement is running faster than regulations, and somehow it is, and the effort to keep up with innovation is challenging. In the end, this is a collaborative effort, I see it more like a ‘relay race’. There is no individual winner, we win together (Innovation & Regulations) or there is no win.

#3 Keeping a sharp patient-driven sense

This is not a trend, but it should be, and it is something that we at Sofgen Pharmaceuticals are hyper focused on. This is what we call the basics. At Sofgen Pharmaceuticals, this has been always our motto: provide innovative solutions to improve worldwide health. Improve! The sharp? The sharp calls for keeping a committed cGMP environment (and that “c” is important!) since it demands us to keep updated with new regulations, to be part of important associations, and participate in the regulatory discussion, to be sharp enough to have the ‘eagle eye’ to reward our clients with confidence and ultimately improve patients and consumer wellbeing.

Q: What are the main pain points for pharmaceutical and nutraceutical manufacturers face when it comes to quality assurance and compliance?

AC: cGMPs are a way to stablish a quality culture linked to continuous improvement. Although GMP requirements are well defined, failures on meeting requirements are still one of the causes of medicine shortages in many countries. A key challenge can be to ‘translate’ the quality and compliance requirements language to the whole organisation to build a robust and effective quality culture across the firm. The better comprehension there is, the better implementation and compliance sustainability.

Another pain point for this industry is data management. There are still some opportunities to improve when it comes to data generation methods and the availability to use it towards achieving a more predictive quality and compliance system.

Harmonising the requirements is also a key aspect. I know this is a pathway the industry and regulators started some time ago and has been improving well, but there are still a lot of work to do.

Q: How can manufacturers overcome these pain points?

AC: Communicate the quality strategy effectively inside the organisation to guarantee everyone has a clear quality mindset and compliance can be involved in each process and with the same goal. To build quality into the product from design to the entire product life cycle is one of the key aspects to overcome challenges that normally appear; definitively the more you invest in development and process transfer, the more successful the commercial stage will be.

Effective data analysis to predict the behaviour of products and processes also will allow manufacturers to be more efficient and continue meeting the requirements at the same time.

Q: How does Sofgen Pharmaceuticals approach the challenge of regulatory compliance and quality assurance?

SM and AC: Yes, it is a challenge! I believe that regulatory compliance requires being proactive. Our Regulatory Intelligence Program provides a systematic approach to capture all the changes and new regulations that can potentially impact our business, products, and processes, and this is where the ‘exciting’ part comes in – to determine what needs to be adjusted or improved in our company, to reflect changes in regulations and industry best practices. This is a never-ending learning and improvement process and an important task for pharmaceutical companies to navigate the evolving regulatory landscape effectively.

From a quality assurance perspective, the transformation of our process to optimise and simplify them to overcome any regulatory challenges, is the key factor. Keep our staff thinking on how to meet the requirements and at the same time do an efficient process is the best approach we can use to guarantee accomplishment of our patient’s needs.

Q: What does best practice compliance management look like for CDMOs?

SM: For this answer, I’ll share the experience of what has worked for us.

#1 Keep up-to-date with the latest regulations, guidance, and requirements. Having a proactive regulatory intelligence team, as mentioned before, will help with this.

#2 Develop internal and external networks: Internally, don’t work in siloes. Compliance, Pharmacovigilance and R&D should all be meeting regularly and sharing knowledge. Externally, join regulatory associations, participate in the regulatory discussion, and secure consultancy services when needed.

#3 Keep a sharp patient-driven sense: we mentioned this earlier.

#4 Understand stakeholder needs: this is more than just ‘having a list’ of their needs or expectations, it is more a how those needs can be satisfied from a regulatory perspective.

#5 From Regulatory Affairs, we strive to make sure that regulations are easily understood since these can be a challenge to ‘explain’. We need to make sure that the appropriate recommendations about regulatory authority expectations, and the consequences if those regulations are not followed, are well understood by all stakeholders.

Q: How do you envision the future of quality and compliance for manufacturers?

AC: In the near future, new technologies and data analysis will sit at the heart of quality assurance. AI and ML are already being used by forward-thinking CDMOs to predict process problems and focus resources on key points to meet regulations in order to guarantee consistent compliance. automatic equipment, which can accelerate the analysis, or can work autonomously. Autonomous equipment is being used for sample preparation, to run dissolution methods, automatic weight and in-line process analysis among others critical tasks.

AI software is being adopted to reduce method development times as well as to develop new APIs and to complement in-product development, for example, helping to predict the solubility of the API, to predict possible incompatibility with some excipients, and to predict the possible impurities that can be formed in a certain product. Having a real-time visibility in the process and its data will accelerate efficiencies and productivity of the drug development framework.

For several years, we have been developing and implementing some of these emerging technologies in our processes, which we have called R&D 4.0, applying the technologies provided by Industry 4.0 to R&D activities to achieve better time-to-market.