Drug risk management/risk analysis is a common tool for drug manufacturing and management. The core requirement is to identify the key and important potential risk points and then to allocate proper resources, which helps enterprises to achieve effective management. Proper leverage of the risk management can support pharmaceutical enterprises saving time and effort. However, due to different reasons, the implementation of risk management system and risk assessment tools is still a difficult topic for them, resulting that the risk management could not play its strengths, even becomes a burden. According to gempex experience, it is not that difficult to complete and master the risk management requirements and risk analysis by using customized solution strategies and combining with standard risk components.
According to the life cycle concept of risk management,gempex experts can provide enterprises with customized, pragmatic and practical risk management systems to achieve comprehensive risk management and management review. And also, we can assist enterprises to carry out risk analysis and assessment for equipment, systems, processes and control strategies, etc., and provide support for the development of qualification and validation.
Experienced in various risk management/risk analysis projects
Covering Multi-field products (chemical drugs, biological drugs, raw materials and package, medical devices, etc.)
Technical consultants with years of experience in the quality department of pharmaceutical companies
