Pharma

We Offer Trusted and Dedicated Service

MBS Pharma offers a full spectrum of FDA-related services and employs an integrated approach—that incorporates the use of scientific and technical expertise—to provide specific, actionable recommendations to our clients

  • CMC and Product Development
  • Document preparation and review (including NDAs, INDs, ANDAs, NADAs, and DMFs)
  • Continuous Improvement

30 Years

of experience offering compliance, regulatory affairs, and technical services

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  • Product Development
  • Regulatory
  • GMP Compliance and Assessments
  • Product Life Cycle Management

Offering Development of Active Pharmaceutical Ingredients CDMO Selection, Technical Services, Oversight and DMF Filing

  • Offering Formulation Development (Oral, Injectable, Topical, Ophthalmic)
  • Analytical method development
  • Cytotoxic, potent molecules, small and large molecules, complex and combination products
  • Handle end to end, complete product development through technical transfer to CMO and to submission to the US FDA (IND, ANDA, NDA, BLA)