dsm-firmenich’s API portfolio elevated by Verilege™

Summary 

• In the world of pharmaceutical innovation, managing the intricacies of regulatory compliance, ensuring ingredient quality, and meeting sustainability targets is a complex task.
• To help drug developers navigate this continuously evolving space with confidence and peace of mind, dsm-firmenich has launched a new expert services program, Verilege™, which specifically supports its active pharmaceutical ingredient (API) portfolio.
• Discover how APIs elevated by Verilege™ can simplify the drug approvals process with fully flexible regulatory, quality, sustainability, and supply chain services.

What are some of the biggest challenges in the pharmaceutical market? Is it increasing scrutiny over regulatory and quality compliance? Geographical risk mitigation in the supply chain? Or escalating sustainability expectations? Drug developers encounter opportunities and challenges throughout the drug development process and managing these complexities is no small task—but they don’t have to be tackled alone. Introducing Verilege™, a newly launched and unique service excellence program that comes with our API portfolio. With Verilege™, drug manufacturers can benefit from a distinct suite of expert services designed to help them enter, navigate, and expand in the pharmaceutical market. Keep reading to explore how Verilege™ can simplify the drug approvals process by addressing common challenges in pharmaceutical innovation. But first, let’s take a closer look at what Verilege™ offers.

Introducing Verilege™ 

We sat down with Kelsey Achenbach, Vice President Pharma at dsm-firmenich, to find out more about the Verilege™ program. She revealed: “At dsm-firmenich, we’re committed to helping our customers launch safe and effective pharmaceuticals. And we know that this can come with its own set of challenges. Understanding potential barriers and having the industry understanding and expertise to address them at an individual level is what makes Verilege™ truly unique. It is inspired by our customers’ needs and designed to support them through the drug approvals process, so they can focus on bringing life-changing and life-saving medicines to more patients worldwide. And the best part? By helping our customers bring safe and effective therapies to market, we get closer to achieving our joint purpose of elevating patient health.”

Verilege™ in action

Discover how Verilege™ can help simplify the journey to drug approvals: 

1. Navigate increasing scrutiny on quality compliance

In fast changing and complex markets, drug developers need to be confident that their drug products are of the highest quality standards, because in pharma, quality is non-negotiable. Our quality services ensure we deliver consistent, high-quality APIs across our global network through:

• GMP-certified facilities adhering to the highest manufacturing standards
• Robust quality control processes
• ICHQ7 compliance for reliable pharmaceutical-grade ingredients
• Continuous investments, with regular inspections by various authorities.

2. Keep pace with evolving regulatory requirements

As regulatory requirements in the pharmaceutical industry tighten, compliance becomes more challenging than ever. Meeting these requirements efficiently not only ensures timely product approvals and market access but also builds trust in regulatory clearance. With the right expertise and solutions, pharmaceutical companies can confidently navigate regulations and compliance to ensure that their medicines reach those who rely on them. Our regulatory services can help streamline and accelerate regulatory filings and product approvals with:

• Comprehensive documentation, including up-to-date dossiers for global registrations and access to the API section of marketing authorization approvals worldwide
• Standard and customizable statements tailored to meet specific market and customer needs
• Personalized assistance with regulatory submissions and documentation to ensure compliance with ICH, US FDA, EMA, and other regional standards
• Regulatory documentation gap assessments and regulatory strategy expertise.

3. Meet rising sustainability demands

The pharmaceutical industry is uniquely positioned to drive social sustainability through the development of medicines that improve public health outcomes. This commitment to human health creates a natural foundation for broader sustainability leadership. As evolving regulations increasingly incorporate environmental targets, pharmaceutical companies have an opportunity to align their social sustainability practices with environmental goals. By proactively reducing greenhouse gas emissions and providing transparent communication about their efforts while supporting community developments and ethical sourcing for instance, drug companies can deliver on environmental and social benefits. Our sustainability services are designed to help drug developers achieve their sustainability goals with:

• Life Cycle Assessment (LCAs) expertise
• Transparent data sharing, including primary data, sustainability targets, and certifications
• Proprietary tools, like our Sustainability Imp’Act Card™ program, which provide science-based metrics on the environmental footprint, traceability, and social impact at an ingredient level
• Expert support for sustainability questionnaires, emission calculations, and co-developing sustainable solutions. 

4. Mitigate supply chain risks geographically

With geopolitical concerns facing global markets, proactive risk mitigation with stable supply chains and a geographically diversified supplier network is key. Our supply chain services ensure access to high-quality APIs via a worldwide network of strategically located production facilities. Assuring delivery against GDP requirements, we help de-risk the supply chain and support the drug development pipeline.

Flexibility to match individual customer needs 

Pharmaceutical developers have their own unique challenges, which is why Verilege™ offers tiered service levels that can be tailored to individual needs. Customers can essentially pick and choose which services they need based on their specific business context and goals, whether the priority is geographical expansion or a specific drug launch in a new market. With this flexibility, we can help drug developers focus on what really matters—bringing safe and effective pharmaceuticals to patients worldwide.