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Services of pharmacovigilance

Services of pharmacovigilance

Dear colleagues!

The company “Pharm-document” is pleased to offer a range of services for pharmacovigilance “turnkey” for the company in Ukraine, CIS countries and Eastern Europe!

We can both create and maintain a system “from scratch” and to assist in the individual stages.

SERVICES:

The implementation of the pharmacovigilance system:

  • The development of a pharmacovigilance system master file (PSMF), reformatting a detailed description of the current pharmacovigilance system (DDPS).
  • Development of SOPs in accordance with existing requirements.
  • Implementation and validation framework for pharmacovigilance data (in the absence of it in the company).
  • Developing the exchange of information on the safety of the drug treaties (SDEA).
  • The development of the audit plan and the inspection plan.
  • Development of pharmacovigilance training plan.
  • Conducting literature monitoring, search for information on the safety and effectiveness of drugs.
  • The development of risk management plans (RMPs).
  • Developing periodic safety update reports PM (PBRERs / PSURs) and ACOs.
  • Preparation of reports about the safety of the drug under development (DSURs).
  • Establishment and management of the further signals.
  • Activity in the specification for the drug safety (CCSI).
  • Preparation of medical product specifications (CCDS).
  • Quality management of the pharmacovigilance system.
  • Seminars on pharmacovigilance.
  • Support – product development, plans regarding the accountability of security.
  • Monitoring of compliance with pharmacovigilance system requirements of current legislation.
  • After marketing pharmacovigilance:
  • Organization of the collection, processing, analysis, coding, entering information in the pharmacovigilance database (case processing).
  • Organization of the process of emergency notifications about unintentional consequences (subject to emergency reporting).
  • Screening the literature (regular monitoring).
  • Preparation of PSURs.
  • signals LZ security management.
  • Providing services of the authorized person responsible for pharmacovigilance.
  • Medical services:
  • Answers the phone users (Ukrainian, Russian, English) 24 hours a day.
  • Processing issues and the introduction of a single register.
  • Analysis after the marketing materials.
  • Development of scientific materials for doctors about your medicines.
  • Development of methodical recommendations.
  • Learn the truth about the pharmacovigilance system in your enterprise – order an independent audit!

We have the best specialists in the country, and our prices will pleasantly surprise you!

Call now!