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, PIL Readability User testing, as well as electronic solutions for pharmaceutical companies and regulatory authorities.
- International and dynamic full-cycle consulting group in Life Sciences
- 15+ years of proven experience operating in the EU, Russia and CIS region
- Professional and highly qualified team
- Full range of RA, PV, Quality and E-Solutions services for Life Sciences
- Partnership with leaders in pharmaceutical and medical device industry
- Proven compliance with high-quality standards
WIDE GEOGRAPHICAL COVERAGE
- European Union countries
- EAEU/CIS countries
- 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
Years of experience and unique competencies
High qualifications and EU certificates
Doctors, Pharmacists, Chemists, PhD holders
We speak more than 20 different languages
For more information visit the official website:
- Riga, Latvia
- +371 6000 3500
- info@inpharmatis.com
- Мoscow, Russia
- +7 (495) 266 02 52
- info@inpharmatis.com