We are experienced drug development scientists who have focused on medical and regulatory affairs.\u00a0 But we are anchored by science in every regard.\u00a0 We assess your product, create a plan to manage pre-approval or post-approval activities, and help you implement that plan.\u00a0 Some refer to it as “strategy”.\u00a0\u00a0 To us, it is good planning and consensus building. \u00a0Presentation summaries \u00a0are examples of our current regulatory (Sunshine Act) views, Pediatric Drug Development views, and our Submission Workflow (abbreviated.)<\/p>\n
For brief slide presentations click here<\/a><\/p>\n So we provide ADVICE<\/strong> and OPINION<\/strong>\u00a0and then incorporate those into a STRATEGY<\/strong>.<\/p>\n We place emphasis on DIALOGUE and Discussion <\/strong>with FDA. For FDA Meeting<\/strong> we work to assure the outcome is successful by thoughtful preparedness-we know what works and what does no.\u00a0 To us, a successful meeting occurs when the Sponsor understands the FDA and the FDA understands the Sponsor.\u00a0\u00a0 And there is a clear Path Forward.<\/p>\n Accordingly, we provide core services such as:<\/p>\n If you are evaluating line extensions or evaluating in-licensing or partnering opportunities, we can help you assess the data package and identify gaps from both a clinical and regulatory perspective, and develop a project plan especially if the plan requires a new IND as for example, when implementing the 505(b)2 pathway.<\/p>\n In all of these areas, we can assume a variety of roles – from carrying out specific-focused assignments to organizing and managing the overall project.\u00a0 Through our network, we can provide whatever your organization needs.<\/p>\n We have Therapeutic Competencies<\/strong><\/a> and Regulatory<\/strong> Competencies<\/strong><\/a> that are deeply rooted in science and supported by many years of clinical and basic science experience.<\/p>\n\n