Contact person
Håkan Hollmark
Försäljning-och Marknadschef
Contact Håkan
Drug product development - small molecules
Developing small molecule drug products requires precise control of physicochemical properties, formulation stability, bioavailability, and safety. Early-stage planning, scalable processes and regulatorily compliant workflows are essential for successful clinical progression.
At RISE, we combine scientific understanding of materials with advanced analytical and formulation expertise to design clinically viable dosage forms. Our integrated approach supports the transition from early concept to stable, GMP-compliant formulations for preclinical and clinical trials, including safe handling of highly potent active pharmaceutical ingredients (HPAPI).
Our drug product development services
We offer end-to-end capabilities across the drug product lifecycle – from dosage form design and solid-state evaluation to analytical method development, stability testing, and clinical manufacturing. Each formulation is tailored to the properties of the API, optimized for manufacturability and bioavailability, and produced as GMP-compliant clinical material under rigorous quality control.
Explore our drug product services or contact us directly to discuss your challenges and needs.
Formulation development
RISE develops formulations tailored to the material properties of the active substance and its intended route of administration. Oral, topical, inhalation and parenteral dosage forms are all supported. Formulation design is guided by data on stability, bioavailability and functional performance. Our team also supports method development, analytical characterization, and optimization for regulatory alignment.
Solid-state analysis and crystallization
Solid-state properties are critical for manufacturability, stability and bioavailability. RISE performs XRPD, DSC, TGA, particle size, porosity and hygroscopicity analysis. Salt and co-crystal screening, crystallization optimization and scale-up troubleshooting ensure robust solid forms suitable for formulation and manufacturing.
Analytical development and stability studies
We develop and validate analytical methods to monitor the quality of drug products. Stability studies can be performed to evaluate formulation behavior over time, supporting decisions on storage conditions, shelf-life, and scale-up. These studies provide the foundation for regulatory documentation, while long-term shelf-life readiness depends on client-specific programs.
GMP manufacturing for clinical material
RISE offers preclinical and clinical trial scale GMP manufacturing of APIs and investigational medicinal products (IMPs), including high-potency APIs. Our services include small-scale production, in-process quality monitoring and documentation aligned with CMC requirements, enabling a smooth transition from laboratory development to GMP-compliant clinical material.
Why RISE?
RISE combines scientific understanding of materials with advanced analytical and formulation expertise to develop clinically viable dosage forms. Our integrated approach supports the transition from early concept to stable, GMP-compliant formulations for preclinical and clinical studies, including safe handling of high-potency APIs (HPAPI).
We operate under ISO 17025 accreditation and follow GMP, GLP, and EMA/FDA guidelines to ensure quality and compliance at every step.
Flexible development support
We offer everything from targeted analyses and short feasibility studies to extended formulation programs. Smaller companies gain access to specialist expertise and infrastructure, while larger organizations can strengthen their teams with specific know-how or additional capacity when needed.
Contact
Do you need support with formulation or clinical material preparation? Get in touch and learn how we can contribute with expertise, infrastructure, and solutions tailored to your project.
