Regulatory Strategy and Submissions

  • Overview
  • Benefits
  • Why Work With NSF?

NSF International provides regulatory solutions and strategic input across a wide variety of therapeutic areas. We offer expert pharmaceutical consulting services and regulatory/clinical support to all sizes of pharmaceutical and biotech companies, investment firms and regulatory or litigation counsel who need experts to interpret or navigate the intricacies of FDA pharmaceutical and biotechnology regulations.

We provide regulatory strategies, based on your corporate objectives, for new therapeutics and combination products, including assessment of applicability of unique programs, FDA approval pathways (e.g. breakthrough therapeutics or orphan drug status eligibility for 505(b)(2)) and lifecycle management of marketed pharmaceuticals and biologics. We also prepare or review relevant regulatory documentation, provide temporary regulatory affairs services or serve as the U.S. agent for pharmaceutical and biotechnology drug applications.

Our experts possess comprehensive knowledge of the regulatory requirements and a wealth of experience from agency interactions in developing numerous products. All efforts are directed by senior staff members with former leadership positions in both the FDA and industry, who have many years of experience interacting with the FDA and other regulatory agencies.

Other services include:

  • Pharmaceutical due diligence services: Assessments of early-stage start-ups for possible investment or established companies with a portfolio of approved drugs for possible acquisitions/mergers
  • Advice on product manufacturing and product specifications: review and preparation of chemistry, manufacturing and control programs
  • Form 483 services: We act as FDA Form 483 consultants to determine root causes of non-conformances, including review, assessment and redesign of data trails, policies, SOPs and CAPAs; systems-based gap analyses; and a combination of audit, consultancy, coaching and education to ensure changes are proportionate, sustainable, easily justified and targeted to prevent risk.
  • Assistance with regulatory agency meeting interactions that includes preparing briefing documents, organizing meeting preparation sessions and leading FDA meetings (e.g. pre-IND, end-of-phase-2 (EOP2), pre-BLA, Type A, Type C and advisory committee meetings)
  • Expertise in non-clinical study design and review
  • Assistance in clinical protocol design and clinical trial support (e.g. CRO selection and contracting, IRB selection and drug management/labeling)
  • Scientific review and medical writing support (e.g. investigator’s brochures, informed consents)
  • In-house or WebEx training on U.S. regulatory IND and NDA processes and approval pathways
  • Review and preparation of Investigational New Drug (IND), New Drug Application (NDA), Biological Application License (BLA), Abbreviated New Drug Application (ANDA) and lifecycle management submissions, such as prior-approval supplements (PAS), all with eCTD format

For more information about FDA and Health Canada related services in quality systems and compliance, email or call +1 202.822.1850.

For European and other international agencies email or call +44 1751 432 999.


NSF provides your company with:

  • Widely recognized senior professionals with former leadership positions in both the FDA and industry
  • Detailed knowledge of industry best practices that spans from early stage preclinical and clinical development to postmarketing approval
  • Regulatory expertise across many product types: biologics (e.g. vaccines, recombinant proteins), small molecules, combination products, biosimilars and OTC and generic drugs
  • Access to a broad network of global subject matter experts across many therapeutic areas
  • An integrated approach that covers the complete product lifecycle from a regulatory and manufacturing (CMC) perspective

Why Work With NSF?

This case study illustrates a real-world example of how working with us can help your company.

Challenge: A privately-held Swiss medical device company developing a novel dental drug therapy contacted NSF to serve as its U.S. agent. The prefilled syringe drug product was considered an NCE and had prior clinical experience in the U.S. as a pre-Investigational New Drug (pre-IND) with the same drug substance, but with other indications using other routes of administration. The company filing the IND application had limited experience in the current regulatory expectations for product manufacture and in the conduct of a Phase I clinical study. The client also needed a comprehensive understanding of product development from the IND phase to marketing application of the drug product in the U.S. (type and number of clinical trials needed, nonclinical data needed at various phase, product manufacturing and control requirements, etc.).

Solution: NSF was involved from the (pre-IND) phase through the conduct of a Phase I/II clinical study. We led the pre-IND meeting with FDA which was followed by the submission of the original IND for a Phase I/II clinical study. NSF supported the client in preparation of the pre-IND meeting package and agency question session. For the IND, NSF supported the client in the drafting of the chemistry, manufacturing and control sections as well as clinical protocol development and drafting of the nonclinical and clinical summary sections, including identification of regulatory risk. We also screened and made recommendations for a contract research organization (CRO), a bioanalytical laboratory, a safety laboratory, clinical sites, a microbiology laboratory, an ECG service company, phlebotomists and a statistician for the conduct of the Phase I/II trial. Following the successful completion of the open-label pharmacokinetic pilot phase of the Phase I/II study at a single site, we assisted in the transition of the CRO for the main blinded portion of the trial to be conducted at multiple sites.

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