Regulatory Strategy and Submissions

Receive customised regulatory pathways to bring innovative pharmaceuticals, biologics, gene and cell therapies and combination products to market efficiently.

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 authorisation. 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.

Gap Assessments

We provide submission-readiness evaluations and remediation recommendations, including reviewing drug or device labelling.

Due Diligence Assessments

Evaluate regulatory documentation and status ahead of your company's major acquisitions with the help of our experts.

Literature Review

We review client documentation and scientific literature to support the entire lifecycle of your product development.

Response Strategy

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 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

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