Pharmaceuticals - , Ankara, Turkey
We were established in 1998 as a ‘' Contract Service Organization (CSO)'' providing completely integrated services. Today, we are a well know Contract Service Organization (CSO) in Turkey, being the first in our field, with the qualification based on our 20 years of experience in Bioequivalance, Marketing Authorization and Biopharmaceuricals, in providing extensive scientific and training services in strict adherence to internationally recognized guidelines and regulations, fully respecting confidentiality.Our Services;Compassionate use proceduresActing as ‘applicant' and ‘holder' for marketing authorization Marketing authorization servicesGMP application and supportExpert report preparationScientific consultancy and trainingFormulation development consultancyProcuring reference/comparator drugs for R%D and bioequivalance studiesProcuring internationally controlled reference/comparator drugs for R&D and bioequivalnce studiedDissolution investigationsBioequivalance and therapeutic equivalance investigationsTherapeutic equivalance for pharmaceutical and biosimilar productsBiowaiver dossier preparationReimbursement dossier preparationOther- Preparing price application filesPharmaceutical assessment studied and legal and regulatory adviceExpert assistance for establishing a company in TurkeyRisk management.
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