Our core competency is life cycle management of the:

  • Medicines
  • Dietary supplement
  • Medical Products
  • Cosmetic products

Customers who trust us


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


  • Authorized person responsible for pharmacovigilance - QPPV
  • Preparation of a master file pharmacovigilance system
  • Telephone hotline
  • Pharmacovigilance training


  • 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

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