Our R&D department is involved in every stage of the development: formulation development, analytical development, preclinical tests and regulatory affairs activities.
The team works in the development of internal products of our development pipeline and also offers CDMO services.
Formulation development and Investigational Medicinal Products manufacturing
We have experience in developing new medicinal products and medical devices, in accordance with the respective international standards and regulations. Most of the products we have conceived and developed in our R&D formulation development department have been successfully brought to the market through partnering.
The development department is equipped with high-tech equipment that allow to develop conventional and non-conventional dosage forms, from the early formulation stages up to the scale-up, validation and industrialization process. Most of the internally developed products have been scaled up from the development department up to the pilot scale and eventually to the industrial scale in our GMP industrial manufacturing facility.
We have a dedicated GMP pilot-scale and clinical manufacturing department which can manufacture solid (tablets, minitablets and capsules), semisolid (creams, gels, ointments), liquid (solutions, syrups, microemulsion) and suppositories formulations. This is the department, where we manufacture and package the Investigational Medicinal Products (IMPs) and the patient’s kits for clinical study supply.
The analytical development team performs method development and validation, drug product release for clinical trial and stability testing per ICH guidelines.
The analytical development laboratories are equipped with the most up-to-date equipment, including for example: HPLC systems with different detectors (e.g., UV-Vis, DAD, RID, ELSD, conductivity), ICP-MS, HS-GC, ion chromatography, LC-MS/MS, differential scanning calorimetry (DSC), dynamic laser diffraction (DLS), dissolution testing equipment, rheometer, optical and infrared (IR) microscope.
The laboratory equipment is managed through a data management system compliant to the US 21CFR Part 11.
R&D regulatory affairs
The dedicated R&D regulatory affairs team assist in preparing submissions (e.g., IMPD, IND and NDA), support in obtaining and maintaining approvals from authorities during product maintenance processes and advise on regulatory strategies answers to health authorities’ inquiries and periodic registrations.
A dedicated non GLP pre-clinical laboratory offer a full range of in vitro and in vivo pre-clinical evaluation studies.