PHARMAGATE – General Regulatory Partner

PharmaGate

PHARMAGATE – a functional and full outsourcing solution provider for professional market access services (regulatory strategy planning, approval for medical use, safety and quality compliance system maintenance, licenses life cycle management) for medical goods and life science industry including pharmaceutical, medical device, food supplements, cosmetic and biotech companies.

PHARMAGATE has successfully supported your business goals in all countries of Eurasia for 10 years.

We support of all aspects of marketing authorization applications and life cycle of the product in geography:

  • Russia, Kazakhstan, Belarus, Armenia, Kyrgyzstan
  • Ukraine, Moldova, Georgia, Azerbaijan
  • Uzbekistan, Tajikistan, Turkmenistan, Mongolia

Our responsibility

  • Strict compliance with international, local regulatory standards, customer policies
  • Optimal timing
  • Activities of high quality within the required project scope

Our approach

  • Partnership for large and small companies
  • Excellence and lifelong learning
  • Commercial awareness
  • Risk management board
  • Flexibility in projects flow
  • Multilingualism

Operations from 2011

  • Number of approvals 600+
  • Number of employees 45
  • Countries of operations 13
  • Number of partners 50+

Credibility

  • Quality management system
  • ISO certified 9001:2015
  • Customers audited – more than 10
  • Quality certification bodies audited – 8
    • Services profile & expertise for all types of medical goods – pharmaceutical products, medical devices, food supplements, special food, hygienic products, cosmetics
    • Consulting for products regulatory & market access strategy
    • All types of regulatory affairs activities for medical use approvals
    • Product’s life-cycle management
    • Pharmacovigilance/safety & quality compliance system maintenance
    • local QPPV/safety desk activities
    • Trainings for industry professionals