Our core competency is life cycle management of the:

  • Medicines
  • Dietary supplement
  • Medical Products
  • Cosmetic products

Customers who trust us

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
NEWS

Follow the latest pharmacovigilance news with us

(UA) Найбільші в історії запуски ліків

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(UA) Хижаки фарми

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(UA) Мін економ розвитку і торгівлі відтермінувало маркування ліків за стандартами SI

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(UA) АІ навчився знаходити хворобу Альцгеймера за 6 років до діагнозу

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(UA) У США витрати на рекламу ліків сягнули $30 млрд.рік

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We help to prepare all the necessary documents for the registration of medicines, medical devices, dietary supplements, and cosmetic products

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