In establishing ERA Pharma Solutions, what was your vision and mission?
ERA Pharma Solutions was the first independent contract R&D business to establish itself in Turkey. We focus specifically on pharmaceuticals. In Turkey, there are many R&D-focused businesses, but they all belong to larger pharmaceutical companies. In Europe, people are familiar with independent, quality control and R&D laboratories, but in Turkey this is not common. The idea for this independent facility came around the time of the then newly pub-lished GMP rules: 2010. Many companies submitted for import products dossiers , and it looks about two years waiting list for the the Ministry audit. The Ministry went after specialty and high priority products first. There was a need to prodtion site transfer of these dossiers to inside of Turkey, in order to avoid time loss. ERA Pharma was started due to this growing need. The Turkish Ministry supported us because they wanted to bring outside manufacturing into Turkey.
Since establishing, how has the company evolved?
Our first project was with Sandoz. We worked with both the local and international branches of Sandoz, which outsourced some of their R&D projects to us After this, we started not only doing technology transfer, but we started to offer services in product development, such as assistance in developing new generics, value-added generics and super generics. We started with one analytical services laboratory, then we added a formulation laboratory and a regulatory department, then a small pilot batch production facility.
Please introduce us to ERA Pharma as the company stands today.
Now, we work as an A-Z partner for product development. A company will come to us wanting to develop a generic tablet of a medicine. We provide supply assistance, product development, laboratory and analytical validation, then we provide a pilot batch in our facility or in CMO, then regulatory dossier preparation. We assit for regulatory process, pricing and reimbursement process subsequently. Sometimes we also assist with scale-up and commercial production too. We provide the pharmaceutical companies the opportunity to develop more high tech new products with less investment in a shorter time.
