Full range of regulatory services and electronic solutions

Inpharmatis is an international consulting group of companies providing a full range of services for registration, pharmacovigilance, GMP and GDP audits, user testing of instructions, as well as electronic solutions for pharmaceutical companies and regulatory authorities.

AREAS OF EXPERTISE

Medicinal Products​, API
Medical Devices
Food Supplements
Cosmetic products

WIDE GEOGRAPHICAL COVERAGE

  • EAEU/CIS countries
  • Baltic countries
  • Italy
  • Switzerland 
  • Ukraine
  • Georgia
  • Mongolia

OUR SERVICES

  • Full range of registration services in the countries of the EAEU, CIS, EU
  • Bringing the registration dossier in line with the requirements of the EAEU
  • Technical transformation of dossier for electronic filing (XML formation)
  • Developing individual modules of the dossier in the common technical document (CTD) format
  • Consulting on all issues related to the registration procedure
  • Pharmacovigilance system establishment
  • Full cycle of drug safety management
  • Provision of services of an authorized / contact person for pharmacovigilance
  • Pharmacovigilance system audit
  • Pharmacovigilance training
  • Services of Qualified Person
  • Quality Systems set up and review
  • Writing of SOPs and other documents
  • Preparation, organization and support of official inspections of the EU and EAEU
  • Training on GMP and GDP issues

  • Electronic document management
  • Pharmacovigilance software
  • Electronization of business processes in the quality system
  • Registration dossier in electronic format
  • Automation of validations
  • Off the shelf programs
  • Custom programs
  • Open seminars
  • Webinars
  • PIL EAEU expertise according to EAEU requirements 
  • Development of a questionnaire and user testing protocol
  • Conduct the validated Readability User Testing
  • Analytical and statistical processing of the results obtained
  • Reports

OUR TEAM

20+ years of experience and unique competencies

High qualifications and certificates

Doctors, Pharmacists, Chemists, PhD holders

We speak more than 30 different languages

For more information visit the official website:

Inpharmatis Logo-(1000x1000)