Development of value-added medicines

The R&D Project Management Department is in charge of tasks relating to all stages of the project life cycle: from executive analysis and project prenomination, to development and achievement of the assumed objective, which is a new product launch. Offering significant added value, the formulations developed at Adamed meet ever-evolving patient needs, which differentiates them from other products on the market.

The Analytics Department is a research unit whose main task is to carry out innovative projects for value-added finished formulations which include the development and validation of new analytical methods for finished dosage forms, semi-finished products, active pharmaceutical ingredients, and starting materials.

The tasks of the Analytics Department support the development of cutting-edge pharmaceutical technologies. The team performs physiochemical measurements and stability studies, develops analytical methods, and defines specification parameters for medicinal products.

The Preformulation Department studies the physical properties of active ingredients, excipients, and finished formulations. These studies are crucial for designing further formulation work based on scientific evidence. 

The department uses a variety of research methods: scanning electron microscopy, optical microscopy combined with digital image analysis, confocal Raman microscopy, XRPD, DSC, TGA, DVS (dynamic vapour sorption), IR, texture analysis, BET specific surface area analysis, and true density.

The Formulation and Technology Department is the unit responsible for technological development to select optimal formulas and manufacturing techniques for solid and liquid dosage forms. The laboratory zone is a state-of-the-art facility equipped with dedicated lines for mixing, dry, wet, and fluid-bed granulation, extrusion, pelletization, tableting, coating, and encapsulation.

The Organic Synthesis Department participates in key projects supporting Adamed’s operations. An important part of the team’s work is conducting API development projects to identify new and economically attractive synthesis paths. The Organic Synthesis Department is also involved in Adamed’s drug development projects and supports the Analytics and Formulation & Technology Departments by providing the highest quality active ingredients and impurity reference standards for APIs. 

Officially opened on 18 April 2018, the R&D Pilot Plant received funding from European Union structural funds. Thanks to the support given by the Ministry of Economic Development, Adamed has been able to implement highly innovative technologies such as Hot Melt Extrusion (HME), bi-layered tablet technology, and fluid bed granulation.

The Regulatory & Pharmacovigilance Department is responsible for obtaining marketing authorisations, ensuring that the approved registration dossiers for all product categories (medicinal products, cosmetics, food supplements, medical devices) are always valid and up-to-date, as well as the functioning of the system for the detection, assessment, understanding, and prevention of adverse reactions or other issues that may be relevant to medicinal products.

The Clinical Development Department is comprised of the Pharmacokinetic Studies Team and the Phase Clinical Studies Team. The former conducts early-phase studies focusing mainly on pharmacokinetic assessment and biological equivalence studies of medicinal products. The Phase Clinical Studies Team performs clinical trials for specific therapeutic indications and non-interventional clinical studies.