We are experienced drug development scientists who have focused on medical and regulatory affairs. But we are anchored by science in every regard. We assess your product, create a plan to manage pre-approval or post-approval activities, and help you implement that plan. Some refer to it as “strategy”. To us, it is good planning and consensus building. Presentation summaries are examples of our current regulatory (Sunshine Act) views, Pediatric Drug Development views, and our Submission Workflow (abbreviated.)
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So we provide ADVICE and OPINION and then incorporate those into a STRATEGY.
We place emphasis on DIALOGUE and Discussion with FDA. For FDA Meeting we work to assure the outcome is successful by thoughtful preparedness-we know what works and what does no. To us, a successful meeting occurs when the Sponsor understands the FDA and the FDA understands the Sponsor. And there is a clear Path Forward.
Accordingly, we provide core services such as:
- IND Submissions
- IND Lifecycle Management
- DMF Submissions and Lifecycle Management
- Orphan Drug Designation Applications/Request
- Orphan Drug Designation Lifecycle Management
- Meeting Requests including pre-IND Type A and B Meetings
- Clintrials.gov Registration (when required)
- cGMP Audits of Manufacturing within a Sponsor or CMO
- Support to Universities for Investigator Sponsored INDs
- Strategic Project Development Plans with Regulatory Success Milestones Noted to help Investment Capital Flowing.
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.
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. Through our network, we can provide whatever your organization needs.
We have Therapeutic Competencies and Regulatory Competencies that are deeply rooted in science and supported by many years of clinical and basic science experience.