Capabilities | FIS - Science you trust

Expertise

Custom API Development

Innovative route design and rapid optimization to identify the most effective lab-to-production path.

Streamlined process development

Smart, phase appropriate workflows that accelerate progress and reduce time to market.

Flexible and scalable manufacturing

Reliable supply from clinical to commercial scale, backed by rigorous quality standards.

Experts in complex chemistry

Advanced capabilities to tackle challenging reactions, impurities, and process robustness.

Collaborative partnerships

Open communication, dedicated technical support, and a proven commitment to being a partner you can trust.

Research & Development

In our R&D unit, scientific insights are turned into hands-on innovation. By focusing on efficiency and agility, we design development strategies to provide our partners with the right capacity at the right time, ensuring rapid, reliable progress from concept to scalable process.

What defines our outstanding R&D

Smart route design

Creative, data driven pathways conceived for robustness, sustainability and seamless manufacturability.

Streamlined process development

Phase-appropriate optimization that accelerates timelines while ensuring high process control.

Advanced analytical capabilities

State-of-the-art tools for impurity profiling, mechanistic understanding and comprehensive characterization.

Scalability from day one

Processes built for a smooth lab-to-plant transition, with predictable performance every step of the way.

Our future growth is supported by key technologies

High potency

Spray drying

Flow chemistry

Peptide synthesis

Biocatalysis

Quality is embedded in every way we operate, improve, and grow

FIS operates through a Corporate Quality Management System designed to ensure consistency, transparency, and continuous improvement across all operations. By integrating governance, standardized procedures, and data-driven decision making processes, we strengthen operational reliability and support the delivery of safe and reliable medicines, while focusing on patients through and through.

Our Quality approach

A unified framework across the entire organization

Our Quality Management System defines how processes are designed, executed, monitored, and continuously improved across our organization. Corporate standards ensure that all our documentation, training, validation, supplier control, data integrity, and lifecycle management are aligned to one another, for a consistent way of working worldwide.

Governance focused on alignment and accountability

A centralized governance model promotes alignment while empowering effective local execution. Shared standards and knowledge exchange strengthen the decision-making process, our operational reliability, and cross-sector collaboration.

Continuous data-driven improvement

Performance is monitored through leading and lagging indicators that support early trend detection and proactive risk management.
Insights from audits, operational performance, and customer feedback are systematically translated into improvement actions that enhance process robustness and efficiency.

Quality embedded across the product lifecycle

Cross-functional collaboration ensures that quality principles are integrated throughout the process, from development to manufacturing and delivery, supporting long-term partnerships and reliable supply.

High potency

Every day, we take on the challenge of transforming scientific ambition into safe and effective treatments. When working with active high-potency pharmaceutical ingredients, technical expertise is not enough: you also need a vision, a responsible approach and an ongoing quality-oriented commitment. Our approach focuses on an integrated development model. We design and fine-tune solid lab-scale processes, and then validate them on an intermediate scale, creating an essential connection between research and large-scale production. With this gradual path, we can anticipate any complexity issues, reduce risk, and ensure a smooth and reliable transition to production.
Safety is another central element in our mission. Safety for the patients who will rely on the treatments, and for the people who foster their development. Through advanced containment technologies, rigorous checks, and a culture of safety deeply rooted in our approach, we protect our people and preserve the integrity of high-potency compounds.

We combine innovation in scalable processes, operational excellence and a strong ethic to help our partners create treatments that really count. Our treatments are carefully designed, produced responsibly and developed around the patients’ actual needs.

Spray drying

Spray drying is a key enabling technology within our small molecule manufacturing platform, supporting the conversion of solutions or suspensions into solid materials with controlled particle size, morphology, and solid state properties. It is applied both as an isolation step and as a tool for material property optimization, particularly where conventional crystallization approaches are not suitable or sufficiently robust.

Our manufacturing facilities feature large-scale spray drying systems that support flexible and reliable GMP production across different volumes. For early development, a laboratory spray dryer enables feasibility testing, process optimization, and smooth preparation for industrial production. Using process modeling technologies, we guide equipment selection, define optimal operating conditions, and ensure predictable scale up.

This integrated approach delivers efficient development, reliable scale translation, and consistent product quality. For our customers, spray drying offers a robust and scalable solution that supports demanding development timelines and long-term commercial supply.

Flow chemistry

Flow chemistry is a fundamental enabling technology within our small molecule development and manufacturing platform, offering enhanced control, safety, and reproducibility compared to conventional batch processing. Continuous flow operation allows precise management of reaction conditions such as temperature and residence time, enabling efficient development of robust and scalable processes, particularly for complex or highly reactive chemistries.

Our GMP ready manufacturing facility is supported by dedicated flow skids, while our development labs provide a full suite of flow reactors, mixers, and analytical technologies for rapid screening and optimization. This integrated approach enables a smooth and reliable technology transfer, efficient scale up through numbering up, and reduced development risk—resulting in faster, safer, and more sustainable flow based solutions designed around your goals.

Peptide synthesis

As peptide therapies move toward the market, efficient and cost effective large scale production becomes essential. Liquid Phase Peptide Synthesis (LPPS) is increasingly adopted for peptide API manufacturing thanks to its scalability and more sustainable profile, with reduced solvent use.

At FIS, we support the transition from clinical development to commercial supply with robust LPPS capabilities, designed for projects where purity, cost control, and scale matter. From simple fragments to complex peptides, we combine strong chemical expertise with large scale infrastructure to deliver reliable, high quality products, from multi kilogram to commercial volumes. All operations are performed under cGMP standards and supported by comprehensive analytical controls. With a proven regulatory track record, FIS is a trusted partner for complex and scalable peptide manufacturing.

Biocatalysis

Enzymatic catalysis is an established and integral part of our small molecule development platform, supporting the efficient execution of selective transformations within modern synthetic routes. Biocatalytic steps are applied where they offer clear advantages in terms of selectivity, process simplification, and overall robustness.

We support our customers throughout the entire biocatalysis development process, from selecting the right enzymes to optimizing reactions and integrating them smoothly into the overall manufacturing process. We focus on creating production solutions that are not only effective, but also scalable and compliant with GMP standards.

We work with a broad range of enzymes and, when the need arises, we work alongside our customers on enzyme improvement to achieve the required performance and ensure a reliable supply. By carefully combining biocatalytic and chemical steps, we enable a straightforward development, predictable scale up, and consistent product quality.