Organizational Development
Our objective is provide a drug development infrastructure in the early stages of drug development and to provide the necessary education and training to facilitate the development of internal staff as the business dictates. In addition to supporting your internal staff we have experience in many areas that we can share. As a partial example, this includes:
- Fast Track Designation and Priority Review
- Type A, B and C Meetings & Their Conduct
- Dispute Resolution
- PDUFA - History and Application
- Orphan Drug Designations
- User Fee Waivers
- Drug Advertising
- Drug Listing
- Labels and Labeling
- Device Registration
- Advisory Committee Meetings
In addition, we have experience in conducting an organizational assessment via a formal process of organizational diagnosis. We do no use a medical model where the 'expert' listens to your symptoms, collects some information and then makes a diagnosis and prescribes a course of action. We believe the 'patient' has a much better prognosis when they make their own diagnosis and therefore are more likely to be committed to the defined course of actions and improvements. We have a model and process for collecting information regarding key functional areas of an organization (leadership, rewards, helpful mechanisms, structure, roles and responsibilities) and providing the information in a manner that allows the organization to determine the areas that are functioning well and need to be maintained and areas that could lead to better organizational effectiveness.