Quality processes without unnecessaries
Process optimization ∙ Risk management ∙ Continuous development
Pharmacovigilance
Providing pharmacovigilance system
Pharmacovigilance plays a vital role in the detection and prevention of adverse drug reactions and early warning of potential risks. Effective pharmacovigilance practices contribute to the long-term business sustainability of a pharmaceutical company. Our company provides all key pharmacovigilance activities:
- Creation, update and optimization of PSMF
- Creation and rationalization of controlled documentation
- Communication with regulators
- Screening of local and international literature
- Training
- Audits
- Ensuring EU QPPV & Deputy, Local Contact Person
Quality management system
Sustainable growth through quality management
Do you need help or advice with implementing partial processes or setting up a Quality Management System (QMS) in your company? QMFocus, s.r.o. is a specialized provider of consulting services focusing on the implementation of a quality management system. We can help you analyze your current situation and help you set up a fully customized QMS for your company.
We offer:
- Setting up a quality Home Office process
- Vendor management
- Staff training
- Compliance
- HR management
- Preparation and maintenance of methodology (SOP)
- Implementation of processes to ensure business continuity
Audits and inspections
Identifying and managing risks in your company
One of the basic rules of our company is: "Know your risks". Our company has many years of experience in setting up and conducting internal and external audit missions. We believe that a proper audit system improves processes and helps in business development.
Our company focuses not only on the comprehensive provision of audit management at our partners, but also on consulting and assistance in managing difficulties concerning even only partial steps or corrective measures.
However, risk identification is not only about the audit area. Our company also focuses on setting up control mechanisms within companies as well as in relation to vendors.
We offer:
- CAPA management including corrective actions
- Preparation for inspections by state authorities
- Actual execution of audits
- Verification of business continuity functionality
- Setting up control mechanisms for continuous risk identification and management
- Setting up an audit and control plan (strategic, tactical, etc.)
- Risk identification and management
Process optimization
Complex project and innovation management
Our great motivation is to do things the right way, without unnecessary frills and excesses, so that our partners can really use their potential and achieve their goals in the long term.
Therefore, our company focuses on testing the optimality of processes while adjusting and furthermore complex and partial project management so that the individual processes are adjusted to the needs of our partners, because everything costs time and money.
We offer:
- Change management
- Complex and partial project solutions
- Lean management setup and management
- Design and implementation of optimal solutions
- Analysis of process settings in terms of their efficiency