Our advantages:
Guaranteed and high-quality comprehensive or segmental assistance in registration process and ongoing support of activities to assess the effectiveness and safety of medicinal products.
Existence of own Pharmacovigilance System.
Implementation and support of Pharmacovigilance System at pharmaceutical enterprises.
Experience of partnership cooperation in Ukraine and abroad.
Experience from the beginning of creation of Pharmacovigilance System of manufacturer / Marketing Authorization Holder (MAH) in Ukraine.
Services:
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PHARMACOVIGILANCE
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REGISTRATION OF MEDICINAL PRODUCTS
PHARMACOVIGILANCE
Implementation, improvement, constant support of Pharmacovigilance System:
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Pharmacovigilance quality system (read more)
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Organizational documents of Pharmacovigilance system (read more)
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Services of responsible persons (read more)
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Risk management (read more)
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Safety information management, literature search (read more)
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Reviews and reports of safety and efficacy (read more)
REGISTRATION OF MEDICINAL PRODUCTS
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Formation of documents and support of Registration Dossier during the process of registration / renewal of medicinal products (LIST OF DOCUMENTS)
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New registration of medicinal product/API;
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Variations to registration materials;
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Audit of Registration Dossier;
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Change of Applicant;
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Renewal process of medicinal product/API;
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Confirmation of compliance of medicinal products manufacturing conditions with the requirements of good manufacturing practice (GMP);
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Obtaining the Сertificate of Pharmaceutical Product (CPP).
Founder and expert of the company
Viktor Usenko
Specialist of Pharmacovigilance.
22 years of experience in pharmaceutical industry.
Establishment and support of Applicant’s Pharmacovigilance System since 2004.
Qualified Person Responsible For Pharmacovigilance and Head of Pharmacovigilance Department for 16 years.
Education:
Higher medical education – O.O. Bogomolets National Medical University
Internship – Specialty: infectious disease.
Qualification: Infectious Disease Doctor.
Advanced training: “HIV, AIDS, viral hepatitis, intestinal diseases”.
Scientific degree - PhD (Medical Science; Specialty – Clinical Pharmacology)
Training – Participation in number of medical conferences, congresses, trainings, seminars in Ukraine and abroad.
Work experience:
2013 – 2021 – PJSC SIC “Borshchahivskiy Chemical Pharmaceutical Plant”, Kyiv; Head of Pharmacovigilance Department; Qualified Person Responsible For Pharmacovigilance.
2006 – 2012 – PJSC SIC “Borshchahivskiy Chemical Pharmaceutical Plant”, Kyiv; Head of Pharmacovigilance Department and Clinical Support (Pharmacovigilance, studies: non-clinical, clinical, including bioequivalence), Qualified Person Responsible For Pharmacovigilance.
1999 - 2005 – PJSC SIC “Borshchahivskiy Chemical Pharmaceutical Plant”, Kyiv; Advertising Representative, Medical Representative, Medical Consultant, Responsible for Pharmacovigilance; Qualified Person Responsible for Pharmacovigilance.
1994 - 2000 – Oleksandrivska Clinical Hospital, Clinical Hospital No.5, Kyiv: intern, infectious disease doctor, Head of Admission Department.