RESEARCH & DEVELOPMENT ACTIVITIES

Research and development operations include formulation development, analytical development, clinical studies and marketing authorization procedures. These operations are performed by specialized scientists.
cGLP, cGMP, cGCP guidances and international and national guidelines and regulations are followed during development studies.

  • T.C. Ministry of Health
  • ICH (International Conference on Harmonization)
  • EMEA (European Medicines Agency)
  • FDA (Food and Drug Administration)
Different pharmaceutical forms (Tablet, Coated Tablet, Modified Release Tablet, Capsule, Sachet, Suspension, Syrup, Gel, Cream, Lotion etc.) are developed in R&D Center. Pilot production of these dosage forms, process validation and scale-up studies are executed in Pilot Production Plant under cGMP conditions.
     

Research & Development is dedicated to perform all formulation development tasks and projects with the most up-to-date regulatory and scientific approaches. It has adequate facilities, trained personnel for pharmaceutical and analytical development, validation and approval. The department has successful records in launching new products.
In order to improve research and development effectiveness, international and national co-operations (Such as; Turkish Universities, TUBITAK, R&D Consultants) are carried out. Bilim Pharmaceutical has developed several pharmaceutical products for international partners.

Bilim follows current developments in machinery, production and analytical technology in order to increase efficiency in research and development operations and invests on these technologies. Information Technologies are widely used to facilitate R&D studies.

Stability studies are performed according to regulations of Turkish Ministry of Health and ICH guidelines. By this mean; quality, efficacy and safety of the product are assured through the life cycle of that product.