Registration of medical and pharmaceutical products

Acceleration the process of withdrawal the high quality, effective and safe products

Pharm Group provides a strongest support in registration of the products such as:

  • Medicine;
  • Medical supply and equipment;
  • Food supplement and substance; 
  • Veterinary product;
  • Cosmetics and perfumery.

Pharm Group’s turnkey registration services include:

  • Translation of dossier;
  • Assistance in preparation of the pharmacological, pharmacovigilance documents, etc.;
  • Submission of the dossier to the Regulatory Authorities;
  • Support in registration period;
  • Full support in customs clearance of products to be registered;
  • Clinical trials, toxicology studies and evaluation of effectiveness;
  • Modification of package design and labeling;
  • Re-registration of pharmaceutical products.

The period of registration:

The registration of drug is a quite long process, but it must not exceed 2 years from the date of application submission. The time for conducting clinical research of the drug (if needed) is not considered in calculating the period of state registration.

Studies and Pharmacovigilance

Drug Research, Evaluation of the Benefits, Harm, Effectiveness and Risk of Drug Use, Marketing Research

Pharm Group closely works with majority of scientific research institutes in Uzbekistan, which are capable to perform:

  • Clinical researches;
  • Toxicological studies;
  • Evaluation of Effectiveness.

The Clients cooperating with Pharm Group may significantly reduce the expenses on researches and studies.

Marketing research:

  • Pharmaceutical market research;
  • Competitive analysis;
  • Demand survey;
  • Strategic development (branding, pricing).

Pharmacovigilance

Pharmacovigilance offered by Pharm Group will cover:

  • monitoring, analysis and evaluation of information on safety of medicine registered;
  • assessment of benefits, harm, efficiency and risk of using drugs.

The professional team of Pharm Group will assist the Clients by:

  • Data collection and analysis for pharmacovigilance and case processing;
  • Screening of literature (regular monitoring);
  • Preparation of Periodic Safety Update Reports;
  • Services of authorized person, responsible for the Pharmacovigilance.

Pharmacovigilance – system for monitoring, analysis and evaluation of Information about safety of registered drugs.

Due to pharmacovigilance system, we are able to improve the safety of use and population health. We can both create and maintain the system from “scratch” and provide assistance at certain stages.