Services of pharmacovigilance
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.
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!