Practical Experience

Practical Experience

Practical experience in regulatory compliance

“Exchange of experience requires talking: with each other instead of about each other.“
(Translated from the German; Ernst Ulrich von Weizsäcker, *1939, physicist)

Regulatory compliance is prominent in every pharmaceutical company; nevertheless, there are always issues for concern. Normally an open exchange of experiences between different companies would relieve the situation, but the topic is too delicate for open discussion since the detection of non-compliance may lead to severe problems for the company.

Looking at the situation from an outside position reveals solutions to complex situations.

My services include:

  • Strictly confidential discussions
  • Analysis of your claims regarding regulatory compliance
  • Tailor-made strategies developed with you and for you

Auditing Regulatory Affairs

„Where all condemn, you need to examine and where all praise, also“ (Confucius (*551 BC), Chinese Philosopher)

Regulatory Affairs, which is frequently the last in the chain and the bringer of bad news, is often seen in a negative light. Being an interface to GMP-functions delivering sensitive GMP-relevant data, Regulatory Affairs takes a crucial position since transmission of erroneous information bears a high risk profile for the qualified person (QP) and the pharmaceutical company. Nevertheless, Regulatory Affairs is not GxP-mandatory; there exist no official requirements to be used as a measure during an audit – but, without an audit there is no basis by which to minimize potential deficiencies.

Many years of experience and a focused view from the meta-level allow an independent audit and assessment

My services include:

  • Taking a holistic view of Regulatory Affairs within the company
  • Interviews with job holders
  • Analysis of interfaces
  • Analysis of available workflows and IT systems
  • Documentation of the audit, assessment and recommendations

Expansive variations (e.g. international production strategies)

Expansive changes in Product Supply, such as the transfer of complete production sites, have a strong impact on Regulatory Affairs. Especially at the beginning of the project the pressure coming from the company is very high.

The regulatory strategy and the professionalism with which Regulatory Affairs handles the project are of vital interest to the company.

My services include:

  • Development of a tailor-made strategy, in full consultation with you, for your specific change
  • Assistance with identifying team members and tools
  • Development and implementation of workflows
  • Assistance in implementation with consulting and coaching
  • Assistance in organizing the flow of regulatory data
  • Training of involved parties at the international level