Regulatory Strategy and Submissions

Receive customized regulatory pathways to bring innovative pharmaceuticals, biologics, gene and cell therapies and combination products to market efficiently.
A group of doctors discusses in a medical office meeting room - Regulatory Strategy and Submissions | NSF

Ready to Bring Your Product to Market?

Contact us today to start the discussion.

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.

Gap Assessments

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.

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 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.

News and Events

NSF Now Offering Live Instructor-Led Virtual Pharmaceutical and Medical Devices Training

May 19, 2020

To complement its face-to-face offering, NSF now offers traditional classroom courses as virtual instructor-led training to support your professional development. Courses are delivered via a combination of live instructor-led virtual classrooms and self-paced online learning. NSF’s coaches are on hand to guide participants through the interactive sessions which also include pre- and post-course activities.

NSF’s Health Sciences Team Joins Fight to Save Lives With More Ventilators

April 23, 2020

NSF’s health sciences team is hands-on in the rapid ventilator manufacturing specification issued by the United Kingdom (UK) government. The UK National Health Service needs thousands more ventilators to help save lives as the country’s COVID-19 pandemic approaches its expected peak and ventilator capacity becomes a challenge.