© 2019 IPHARMA

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IPHARMA provides full cycle of clinical development from early phase trials to registration and post-marketing PV.

Services

The main purpose of the Phase I study is to evaluate safety and tolerability of the new drug. As for bioequivalence studies the assessment of the pharmacokinetic profile of the original and generic drugs is performed. Most of these studies are conducted in healthy volunteers and required the specific conditions from the sites and contract research organizations.


IPHARMA conduct Phase I and bioequivalence trials in leading sites which have accreditation for such studies. Special attention is paid to safety of healthy volunteers.


We conduct a full range of studies to register generics, fixed dose combination and extended release drugs:

  • Pharmaceutical

  • Pharmacokinetics

  • Therapeutic

  • pharmacovigilance

  • data management, biostatistics

  • logistics and warehouse

  • central and bioanalytical laboratories

  • quality assurance

Clinical trials services (Phase I and bioequivalence):

  • documents development

  • regulatory support

  • project management

  • clinical monitoring

  • medical monitoring

  • organizing the work of Data safety monitoring board

List of the MoH approvals for the conduct of clinical trials - Phase I and bioequivalence: