OtiPharm®

RESEARCH

Our Competencies
Our regulatory specialists have their own experience in the pharmaceutical and biotechnology industries.

Managing the lifecycle of a medicines – is our core competence

Our team is represented by scientists and clinicians who have the appropriate qualifications (certification of GCP, PhD).

l Medical writing

Expert analysis of regulatory documentation for a medical product, medical device, food supplemet, cosmetic product, writing of accompanying documentation for submission to the regulatory agency

Reviews:

  • Drug quality review (quality overview)
  • Preclinical data overview of the drug (preclinical overview)
  • Clinical data overview of the drug (clinical overview)

Summary:

  • Summary of quality
  • Summary of preclinical data
  • Summary of clinical data

Pharmacovigilance Reports:

  • Risk Management Plan (RMP)
  • ACO – addendum to the clinical overview
  • PSUR – periodic safety update report
Z Pharmacovigilance
We offer pharmacovigilance services:

  • Audit of the system
  • Services of the Qualified Person Responsible for Pharmacovigilance (QPPV)
  • Preparation and updating of regulatory documents:
    • Master File of Pharmacovigilance System
    • Risk Management Plan (RMP),
    • Addendum to Clinical Overview
    • Periodic Safety Updated Report (PSUR)
    • Documents of the quality system of pharmacovigilance
  • Standard Operating Procedures
  • Position functions of pharmacovigilance specialists
  • Regulations on subdivisions in pharmacovigilance
  • Maintaining the Database
Drug research program
OtiPharm® Research offers a wide range of services to support experimental, preclinical and clinical studies.

Our services includes:

  • Development of a clinical research plan
  • Creation of a clinical trial protocol
  • Selection of clinical base
  • Submit an application for a clinical trial to regulators and ethics committees
  • Maintenance and monitoring of clinical trials
  • Preparation and approval of a clinical trial report
  • Pharmacovigilance during the clinical trial
  • Statistical studies
Drug development program

Our regulatory specialists have their own experience in the pharmaceutical and biotechnology industries.

We provide preparation of accompanying documents for submission to the regulatory agency, control of the stages and terms of registration of medicines, medical devices, food supplements , cosmetics

Audit of regulatory affairs
OtiPharm® Research regulatory experts  has experience both as independent experts and experience in regulatory bodies and leading scientific institutions in Ukraine.

Model

  • Conducting pre-audit, audit
  • Providing recommendations on the modernization of production processes and updating the regulatory and technical documentation in accordance with modern international requirements.
IT-platform for pharmacovigilance and regulatory system

We offer our customers a high-tech IT-platform with possibility of simultaneously connection up to 100 users of one client. With preservation of pharmacovigilance data in E2B r2 format. And structuring of data in CTD format for the IT-platform for regulatory. With possibility to quick access from any gadget.

The IT-platform functionality overrides:

  • Systematic monitoring of data from pharmacovigilance
  • Continuous analysis of all information regarding risks associated with the use of drugs
  • Provision of reliable and valid data on serious and non-serious adverse reactions to regulatory bodies in time
  • Proper documentation of pharmacovigilance activities
  • Timely notification on the safety of medicines to health care professionals.
Regardless of whether you need assistance in your daily regulatory activities or only a competent expert advice, we can satisfy your needs
OtiPharm® research
Development of solutions that meet industry standards, as well as the goals and requirements of each client

Made by