(UA) OtiPharm®

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

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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 […]

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