Pharma, Biologics and Biotech Regulatory Affairs Consulting

  • Overview
  • Benefits of Regulatory Consulting
  • Why Partner With NSF?
  • Regulatory Consulting Services

NSF International provides FDA consulting services to support the development, marketing, regulation and stewardship of pharmaceuticals and biologics. NSF’s core specialty is the development and execution of strategic efforts to support pre-market approval and post-market requirements. Our clients include multinational companies, mid-size and small firms, privately held companies, investors and outside regulatory and litigation counsel.

Benefits of Regulatory Consulting

NSF provides your company:

  • Widely-recognized senior professionals with former leadership positions in both the FDA and industry
  • Detailed knowledge of industry best practices with particular expertise in the area of chemistry, manufacturing and controls (CMC)
  • Regulatory expertise across many product types: novel biologics, large and small molecules, combination products, and biosimilar and generic drugs
  • Broad network of subject matter experts across many therapeutic areas
  • Total product lifecycle perspective from pre-IND development through post market

Why Partner With NSF?

NSF maintains a commitment to outstanding service and quality. We focus on achieving your business objectives through the use of sound science and proven expertise. NSF can assist across a wide range of therapeutic areas, product types and regulatory specialties. We provide initial consultations as a professional courtesy.

Regulatory Consulting Services

NSF provides consulting across a variety of therapeutic areas, product types and regulatory specialties. Our services include:

  • Regulatory consultation: Target product profiles, regulatory strategy, orphan drugs, unique and combination products (due diligence, regulatory pathways) and  global BLA/NDA/MAA/CA strategy: response to agency questions
  • Regulatory submissions:  Orphan drug applications. Fast track designation, IND, ANDA, NDA and BLA filings as well as post-marketing submission support (PAS, CBE-30, BLA, REMS reports)
  • Meeting preparation: Pre-IND, end-of-phase-2 (EOP2), pre-BLA, and advisory committee
  • Clinical study design and evaluation: Patient population identification, study site evaluation, endpoint selection, statistical analysis plans, study reports and manuscripts, and publication development
  • Global regulatory filings

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