Team

CEO – Maksym Rymar

• Higher degree in pharmacy, PhD in pharmaceutical sciences.
• 12 years of experience in the pharmaceutical industry, more than 30 publications in the field of quality control, standardization and drug development. Knowledge of the legislation on registration, pharmacovigilance, and manufacturing certification. Organizes the company' s work and is responsible for communication with clients.

Regulatory Affairs Department

Senior Specialist in Regulatory Affairs – Yuliia Filenko

• Higher biotechnology degree.
• Responsible for registration/renewal and variation processes. Analyzing the applicant' s documentation for compliance with the regulatory requirements of Ukraine, the EU, and the FDA. Control over the stages and timing of the development of medicinal products planned for registration. Over 15 years of experience in the pharmaceutical industry (5 years in quality assurance and 10 years in registration)

Senior Specialist in Manufacturing Certification and Regulatory Affairs – Yuliia Kruchynenko

• Higher degree in chemistry and pharmacy.
• Responsible for certification of pharmaceutical manufacturing. Conducting regulatory procedures: registration, variations. More than 12 years of experience in registration of medicinal products, medical devices, dietary supplements and recognition/certification of compliance of pharmaceutical manufacturing with GMP requirements. Knowledge of regulatory legislation of Ukraine, CIS and EAEU countries.

Regulatory Affairs Manager – Nataliia Surtaieva

• Higher degree in pharmacy.
• Responsible for supporting regulatory procedures, preparation and submission of registration dossiers, proofreading and translation of registration documents. 10 years of experience in the pharmaceutical industry.

Pharmacovigilance Department

Senior Specialist in Pharmacovigilance – Chalenko Oleksandra

• Higher degree in pharmacy.
• Responsibilities: Contact person responsible for pharmacovigilance for foreign applicants, organizing and conducting pharmacovigilance training for clients, developing pharmacovigilance documentation, support with passing audits from the State Expert Center. 8 years of experience in pharmacovigilance of domestic and foreign pharmaceutical companies.

Pharmacovigilance Manager – Kateryna Novoselska

• Higher degree in pharmacy.
• Responsible for the development of pharmacovigilance reports; monitoring of literature on safety information; development and variations to instructions for medical use; maintaining the pharmacovigilance system at the proper level. Over 5 years of experience in pharmacy and pharmacovigilance.