(UA) OtiPharm®

Skip to content [#content] Medical writing Services Pharmacovigilance News UA RU EN Contact us Our core competency is life cycle management of the: Medicines Dietary supplement Medical Products Cosmetic products OUR SERVICES Contact us Customers who trust us SERVICES Full accompaniment of pharmacovigilance and regulation for pharmaceutical companies Registration of medicines Registration and re-registration of medicines, medical devices, dietary supplements Management of safety and quality of medicines Licensing and certification of production Drug Safety Reports We prepare reports on drug safety in 3 languages ​​- Russian, Ukrainian, English Risk Management Plan (RMP) Addition to the Clinical Data Review (ACO - Addendum to Clinical Overview) Periodic Safety Report (PSUR - Periodic Safety Update Report) Reviews and resumes Overview and summary of the quality of the medicinal product (Quality Overview / Summary of Quality) Preclinical Overview / Summary of Preclinical Data Clinical Overview / Summary of Clinical Data Pharmacovigilance Authorized person responsible for pharmacovigilance - QPPV Preparation of a master file pharmacovigilance system Telephone hotline Pharmacovigilance training Development Roadmaps of preclinical, clinical research and registration Preclinical and clinical trial protocols Bio-statistics High-tech IT platform for pharmacovigilance and regulatory Ability to simultaneously connect up to 100 users of one client Saving pharmacovigilance data in E2B r2 format Structuring data in CTD format Access from any mobile device 24/7 LEARN MORE DOWNLOAD PDF NEWS Follow the latest pharmacovigilance news with us Active work is underway to develop vaccines against coronavirus As of December 2, 2020, 41 coronavirus vaccines are in the first phase of research, 17 vaccines are in the second phase and 13 are in the third phase. 7 vaccines are allowed for limited use. (https://www.nytimes.com/interactive/2020/science/coronavirus-vaccine-tracker.html) The UK government allowed the use of Pfizer / BioNTech vaccines on 2 December. The vaccine will […] Learn more (UA) Найбільші в історії запуски ліків Sorry, this entry is only available in Ukrainian. Learn more (UA) Хижаки фарми Sorry, this entry is only available in Ukrainian. Learn more (UA) Мін економ розвитку і торгівлі відтермінувало маркування ліків за стандартами SI Sorry, this entry is only available in Ukrainian. Learn more (UA) АІ навчився знаходити хворобу Альцгеймера за 6 років до діагнозу Sorry, this entry is only available in Ukrainian. Learn more We help to prepare all the necessary documents for the registration of medicines, medical devices, dietary supplements, and cosmetic products DOWNLOAD PDF Contact us Contacts info@otipharm.com +38(067) 467 06 56 Address Aviakonstruktora Igor Sikorsky Street, 1B, office 165, 04112, Kyiv, Ukraine Social Network © Otipharm Research All rights reserved. Consent to the use of personal data. Ми безкоштовно визначимо, чи можливо зареєструвати ліки Δ