REGULATORY/REGISTRATION SERVICES

 

PharmConsult provides you all-round support in gaining  CIS pharma market 

From advice and guidance, to full-spectrum regulatory support, we focus on following services:

 

Registration and submission support

  • Registration dossier preparation (in russian, english and other languages if needed)
  • Adaptation of documentation provided in compliance with the CIS legislaion (Belarus, Kazakhstan, Russian Federation)
  • Primary and secondary packaging mock-up preparation

Life-cycle management of regulatory documents

  • Registration dossier submission to competent authorities (Ministry of Health)
  • Organizing and conducting necessary preclinical and clinical research
  • Comparative dissolution testing
  • Obtaining permits and handling official queries and resolutions
  • Preparing answers, reports in accordance with queries

Translation&Medical Writing - Language Support and Expertise you can rely on

  • All  our translators are qualified to an MsC, PhD or MD level and have at least 5 years of experience translating medical documents.
  • Your sensitive and confidential documents are safe with us. We use secure file systems, and all of our translators work under a binding NDA.
  • We meet and exceed translation quality standards, and guarantee our translations will be error-free, or we'll update them free of charge.

Marketing Research

  • Evaluation of the need in investigated medicinal product on the local pharmaceutical market and its sales potential by conducting  sales-dynamics research and analysis for various treatment group product  in retail, hospital, and reimbursement segments

Consultancy 

  • We want to make your entry to CIS pharma market smooth and successful. We are ready to be your dependable partner and provide you any help and consulting needed to reach this goals. 

 

CONTACT US NOW

info@pharmconsult.org

+375 44 783  55 74 (tel)

+ 375 17 372 45 56 (tel/fax)

PHARMACOVIGILANCE
PHARMACOVIGILANCE

Outsourcing service of pre-registration and post-marketing pharmacovigilance (PVG) in the Republic of Belarus, including:

  • Assignment of a Qualified person for pharmacovigilance;
  • Safety monitoring of marketed drugs;
  • Literature screening to detect adverse events;
  • Preparation of Periodic safety update reports and other
TRANSLATION AGENCY
TRANSLATION AGENCY

With a solid background in this industry, we have a team of experts with years of experience in all range of medical and technical translation.

We propose:

  • Translation by a senior medical translator, with specialization in the subject matter and regulatory expertise.
  • Proofreading/editing by a second equally qualified translator.
  • Confidentiality Agreement to guarantee protection of the Customer confidential information

 

 

JOIN OUR TEAM
JOIN OUR TEAM

 Vacancies at PharmConsult:

  • Reguatory Affair Specialist
  • Non-staff Translator
  • Sales Manager (Pharmaceutical raw materials)

 Please email your CV to info@pharmconsult.org and specify your name and the position title in the email subject. 

Minsk, Republic of Belarus
www.pharmconsult.org