EL VISTA CONSULTING LLC

EL VISTA CONSULTING LLCEL VISTA CONSULTING LLCEL VISTA CONSULTING LLC
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EL VISTA CONSULTING LLC

EL VISTA CONSULTING LLCEL VISTA CONSULTING LLCEL VISTA CONSULTING LLC
  • Home
  • Services
  • Contact Us

Some of Our Services

CMC Development

Strategic Compliance

Regulatory Affairs

  • Analytical method
  • Manufacturing
  • Formulation (Solid dose, injectable, inhalation)
  • Container closure system
  • Combination product
  • Advanced technology medicine product

Regulatory Affairs

Strategic Compliance

Regulatory Affairs

  • Regulatory strategies and gap analysis
  • Authoring CMC dossier in IND/IMPD/NDA/BLA/MAA
  • Agency meeting and scientific advices
  • Post-approval life cycle management
  • Due diligence

Strategic Compliance

Strategic Compliance

Strategic Compliance

  • Quality System review
  • cGMP audit and pre-approval inspection
  • Data integrity
  • Analytical/Process investigation
  • Remediation (warning letter and 483)

EL VISTA CONSULTING

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