Maintaining Compliance Every Step of The Way
Without ensuring all Regulatory Aspects are appropriately handled, all of the diligent work in developing and planning a trial will be wasted.
ClinSmart keeps compliance at each step of a project regardless of whether our Regulatory Services are being engaged on a project or not.
We are ready to work with your team to analyze the regulatory aspects of your upcoming project.
Compliance services ClinSmart provides includes:
- Acting as a regulatory agent with FDA on your behalf
- Develop and/or review Regulatory Strategies
- Organizing pre-IND and Pre-NDA meetings and submissions
- Prepare eCTD and review submissions to the FDA and electronically submit them through FDA’s ESG.
- Coordinating special FDA meetings including End of Phase II meetings and Special Protocol Assessments as may be required
- Auditing for pre-approval inspections and general cGxP compliance for clinical sites, manufacturing sites, and packaging sites
- Overseeing QA review and release of all data