MBR Consulting S.C. – your partner in Pharmacovigilance
Pharmacovigilance is the science and actions relating to detection, evaluation, understanding and prevention of adverse effects or any other likely medicine related problems. The main aim of pharmacovigilance is to improve patient care and safety in relation to the use of medicines and other interventions. Despite all the benefits of medicines in disease management, there continues to be problems related to adverse reactions that are important cause for morbidity and morality. Significant harm to even a few patients not only destroys the credibility of the medicine, the patients also tend to loose trust on health system. A good Pharmacovigilance system will identify the risks in the shortest possible time, so that any harm can be avoided or minimized. MBR Consulting provides Pharmacovigilance resource for the small and big national and international pharmaceutical industries.
Our team of highly experienced pharmaceutical and regulatory affairs consultants and associates can provide expert and cost-effective solutions for:
- Pharmacovigilance systems, processes and procedures
- Full Quality Management System with comprehensive SOPs, Quality Control, audits and compliance metrics
- Regulatory compliance
- Training
We can support you in:
- Medical Products
- Medical devices
- Veterinary products
Services include support for:
- Safety surveillance
- Single Case processing and assessment for expectedness, unexpectedness etc.; triage and tracking all cases; initial and final regulatory assessments; MedDRA and WHO-drug coding; development and maintenance of Analysis of Similar Events; complete medical monitoring support; processing of expedited ICSRs to regulatory authorities
- PSURs, Clinical Expert Reports
- Safety Overviews
- Signal review, benefit-risk assessment
- PHV Authorities Inspection
- Process review and improvements
- Risk management strategies
We can cooperate with you:
- on long term contract with full support in Pharmacovigilance
- on long term contract with partial support for you (ex. PSUR preparation)
- on projects – you can outsource some part of your responsibility or full responsibility for some period of time.
- Preparing/ reviewing of procedures
- Preparing of Pharmacovigilance Master File
