Every product or process has associated risks.Every member of vigilare bio pharma team has worked with or for many leading pharmaceutical and chemical companies.
We deliver world-class financial and operational objectives with risk management solutions that are consistent with your firm. we provide the depth of experience to assess the unique risks of industry verticals which No other firm in the world can offer.
The significant costs of development and research , the risks involved in testing and manufacturing , and quickly changing environmental laws are among several factors that combine to present complex financial and operational challenges to the
pharmaceutical/chemical industry..
Risk Management
- US Risk Mitigation and Evaluation Strategies (REMS) and REMS assessments
- EU Risk Management Plans (RMP) including safety specification and pharmacovigilance plans
- Developmental RMP (DRMP)
An effective quality risk management process ensures the high quality of drug product to the patient. In addition quality risk management improves decision making if a quality problem arises.
There are a number of areas of opportunity that where the potential risk could be managed, these include:
Process
Materials
Distribution
Patient
Facilities
Manufacturing
Ultimately, applying risk management to pharmaceutical industry should reduce the number of threats or minimize their impact through the consistent use of the tools/methods and periodic review.