The Business Model
Alkemira's distinctive and disruptive trait lies in its complete independence from industrial manufacturing. By choice, the company owns no production facilities of its own and remains free from the constraints tied to the equipment typical of a CDMO, guaranteeing its clients an approach fully oriented toward formulation excellence and success through an integrated model that conceives development not as a sequence of fragmented steps, but as a fluid, continuous process that preserves scientific logic from the laboratory all the way to commercial production.
- Constraint-free design: Alkemira develops the formulation based exclusively on the chemical-physical and therapeutic characteristics of the molecule, with no internal industrial conditioning.
- Formulation flexibility: develops solid, semi-solid, and liquid finished pharmaceutical forms, both conventional and innovative.
- Core business and application areas: the core business is drug development (Rx & OTC), but the company also applies its expertise to other healthcare categories, such as substance-based medical devices, foods for special medical purposes (FSMPs), nutraceuticals, and functional cosmetics.
- Qualified and flexible network: collaborates with a highly selected network of CMOs for tailored external production of clinical and commercial batches, and of CROs for the rigorous management of pre-clinical and clinical studies.
- Targeted CMO selection: selects the ideal manufacturing partner and technology together with the client, evaluating scale, regulatory requirements, target market, and costs.
- Industrial freedom: the development dossier remains entirely the client's property, who retains full autonomy to choose the manufacturing partner according to their own needs.
Infrastructure and Analytical Services
The heart of Alkemira lies in the team's expertise and its 800 m² of in-house laboratories dedicated to galenic development, analytics, and QC:
- Technological Development and Prototyping: spaces equipped for formulation and process development and optimization, including the production and packaging of small-scale non-GMP batches for prototypes and preclinical studies.
- Advanced Analytical Services: laboratories dedicated to the development, validation, and transfer of analytical methods, as well as R&D testing and Quality Control (QC) activities.
- Prototype characterization and performance studies: stability programs following ASAP approaches and, where applicable, in accordance with ICH and GMP requirements, robustness studies, comparison with the reference product, dissolution and release testing, viscosity and rheological behavior, as well as other functional tests depending on the pharmaceutical form.