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Regulatory activities.

  • 50+ submissions
  • 100% approved
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70+

Drugs registered

Registration:

X7 guarantees a seamless drug registration process. Our regulatory department has performed more than 70 problem-free submissions to Russian, USA and EU regulatory authorities.

Due to properly prepared initial submission packages, almost 100% of studies overseen by X7 were granted approvals in a timely manner.

Results:

As a result of our activities, more than 20 drugs have been registered on the pharmaceutical market.

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Category
Strategy and consulting
Clinical trials
Registration
Post-authorization clinical studies
Pharmacovigilance

Registration strategy and Сonsulting
Registration strategy development
Budgeting
Study feasibility
Vendor selection
Data search and analysis

Clinical trials
Development of medical documentation and biostatistics
Monitoring
Data management
Patient home visits
Bioequivalence study
Therapeutic equivalence studies

Registration
Audit of the registration dossier
Dossier eaeu
Conversion of registration dossier into xml format
Pil readability user testing
Turnkey registration

Post-authorization clinical studies
Phase iv studies
Non interventional studies
Investigator initiated studies
Post authorisation safety study
Marketing research

Pharmacovigilance
Building a pharmacovigilance system
Safety in clinical trials
Pharmacovigilance audit
Pharmacovigilance contact person

Blog
Contacts

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