Regulatory Strategy and Submissions
With the expert guidance of NSF's former regulators and industry professionals, establish a foundation for regulatory success throughout your product lifecycle.
Regulatory Strategy Reports
Our strategic assessments of regulatory requirements address business needs for pharmaceutical and biologic market authorization. We offer evaluations of product classifications, submission types, data requirements and timelines.
Regulatory Development Strategies
Create viable clinical, non-clinical and CMC development strategies, including orphan drug, fast track, breakthrough therapy or accelerated approval pathways.
We provide submission-readiness evaluations and remediation recommendations, including reviewing drug or device labeling.
Due Diligence Assessments
Evaluate regulatory documentation and status ahead of your company's major acquisitions with the help of our experts.
We review client documentation and scientific literature to support the entire lifecycle of your product development.
Our former regulators and industry experts can lead agency or pre-submission meetings, serving as your U.S. agent and developing effective response strategies.
Regulatory Agency Meeting Facilitation
We support your company's regulatory agency meetings by preparing briefing documents, sending meeting requests, conducting meeting preparation sessions and facilitating meetings with the FDA and other regulatory bodies. We specialize in pre-IND, end-of-phase-2 (EOP2), pre-BLA/NDA, Type A, Type C and advisory committee meetings, as well as emerging technology program meetings.
Our services also include:
- IND, BLA/NDA, 505(b)(2), ANDA, DMF
- Investigational New Drug (IND)
- New Drug Application (NDA), including 505(b)(2) NDA
- Abbreviated New Drug Application (ANDA)
- Drug master file (DMF)
- Biologics License Application (BLA)
- Request for Designation (RFD) / Pre-RFD
- Advisory committee preparation
- Lifecycle management supplements
- U.S. agent representation
Ready to Bring Your Product to Market?
Contact us today to start the discussion.
NSF Health Sciences Journal: Time to Rethink - Issue 47, 2020
Insights and Expertise
White Paper: Data Integrity and Warning Letters
Insights and Expertise
White Paper: U.S. Regulatory Update on COVID-19