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.

Our strategic assessments of regulatory requirements address business needs for pharmaceutical and biologic market authorisation. We offer evaluations of product classifications, submission types, data requirements and timelines.

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 labelling.

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.

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 specialise in pre-IND, end-of-phase-2 (EOP2), pre-BLA/NDA, Type A, Type C and advisory committee meetings, as well as emerging technology programme 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