Workflows

Workflows

Workflows for regulatory compliance

The pressure on Product Supply to reduce costs, and the extensive guidelines on variations, have a high impact on Regulatory Affairs. An increase in personnel is normally not an option. Incomplete overviews and unclear responsibilities can result in repetition of work which leads to wastage of capacity. Something being overlooked risks a company crisis.

Straightforward compliance workflows for regulatory assessment of changes relieve the capacity constraints and protect against crises.

My services include:

  • Development of compliance workflows for regulatory assessment of changes
  • Supporting development of an IT solution
  • Assistance in implementation with consulting, coaching and tracking

Mediation of workflows between Regulatory Affairs and Product Supply

Traditionally, Regulatory Affairs and Product Supply have been positioned separately in a pharmaceutical company and have different philosophies and goals. Especially at this interface, efficient and harmonious workflows are of high importance since friction causes delays in changes (delays in lowering the cost of goods) and the occurrence of non-compliance, which may result in high risks for the company.

Understanding the philosophies of both Regulatory Affairs and Product Supply establishes a sound basis for the company’s goal to carry out changes in a minimum amount of time and to sell products in full compliance.

My services include:

  • Consulting and coaching for Regulatory Affairs and Product Supply
  • Development of common workflows
  • Support in finding mutual agreement on risk-management

Interaction between Regulatory Affairs and Research & Development

In cases where a pharmaceutical product develops under its own momentum, and is only afterwards given to Regulatory Affairs to be processed, neither time-to-market nor the approval results will be adequate in relation to the amount of money spent. If several products develop in this same style in parallel the expert functions involved experience priority-conflicts thereby decelerating the entire development. The overall development pipeline as well as the single approvals for marketing authorizations can no longer be managed appropriately.

Transparent and recognized processes designed for controlled interaction between R&D and Regulatory Affairs decrease the time-to-market and allow the steering of the development pipeline.

My services include:

  • Development of processes to steer Research & Development towards the desired marketing authorization
  • Development and definition of generic milestones
  • Development of tracking systems
  • Development of roles, responsibilities and reporting lines within the project organization
  • Development and implementation of supporting IT-systems
  • Implementation by documentation, training and train-the-trainer