OtiPharm® Research Services ⚡ | (UA) OtiPharm®

Skip to content [#content] Medical writing Services Pharmacovigilance News UA RU EN Contact us Full accompaniment of pharmacovigilance and regulation for pharmaceutical companies Our team is represented by scientists and clinicians with the appropriate qualifications (GCP, PhD certification confirmation). We will determine for free whether it is possible to register drugs. Δ AN APPROACH We solve problems CEO / Owner Audit of the regulatory system and the status of the dossier Turnkey procedures control Pharmacovigilance function Writing Clinical Development Plan Medical Director Determination of the type of medicinal product Preparing a dossier (medical writting) Production licensing and GMP Development and support of Clinical Development Plan QPPV and pharmacovigilance manager Pharmacovigilance system audit Medical writting - RMP preparation, DCO (AddCO), PSUR Preparation of Pharmacovigilance and SOP System File Wizard Creating and maintaining a hotline Pharmacovigilance training Regulatory Manager Determining the type of procedure Medical writing - preparation of a review of preclinical data Tracker of regulatory procedures Development and support of Clinical Development Plan 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 Quality/Quality Overall Summary Nonclinical Overview/Nonclinical Summary Clinical Overview/Clinical Summary 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 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