Experienced Regulatory Program Management
A consultancy with proven success navigating the life science landscape to develop regulatory strategy and serve patient needs
Expert Navigating Regulatory Paths
Broad and in-depth life science industry experience
US Authorized Agent
Lead and support staff in preparation for regulatory authority meetings and provide input to submission strategy and other critical regulatory documents.
Cross-Functional Team Leadership
Matrix manage subject matter experts to derive quality and on-time regulatory documents and create quality management systems.
Regulatory Interpretation
Understanding of guidances and interpretation of regulatory feedback to take appropriate action.
Gap Analysis
Actively collaborate with all functions to conduct due diligence, provide regulatory insight, and vet vendor budgets to reduce risk.
Project Management
Overseeing the timeline development and implementation of regulatory deliverables for assigned products to meet milestones.
Clinical Translational Research
Develop clinical trials and use real world evidence (RWE) to bring innovations to patient care.
FDA Regulatory Consulting
Experience yields successfully reaching the regulatory path summit
CDER and CBER Submissions
- Investigational New Drug applications (IND)
- New Drug Applications (NDAs).
- Biologics License Applications (BLA).
- Information Responses (IRs)
CDRH Submissions
- Q Submissions.
- Ivestigational Device Exemptions (IDEs).
- 510(K) submissions.
- De Novo Submissions
