Risk Assessment

Risk assessment

Risk-management for regulatory compliance

“The basis of every true responsibility is to realize the real meaning of what you do.”
(Translated from the German; Max Steenbeck (1904-81), physicist)
(Max Steenbeck (1904-81), dt. Physiker)

Regulatory compliance represents a risk factor to a pharmaceutical company’s manufacturing authosization . The large number of regulatory requirements for variations can act as a hindrance to full compliance since human capacity cannot be increased extensively and product supply must be kept running. The dilemma is inevitable.

Clear company guidelines for handling changes allows deliberate decision-taking for risk management in regulatory compliance.

My services include:

  • Development of tailor-made decision trees and rules
  • • Assistance in implementation with consulting, training and tracking