Visionary Pharma Consulting LLC
Consulting with Vision
Biologics/Pharmaceuticals
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Services


Regulatory Filing 

  • Write and review the Chemistry, Manufacturing and Controls (CMC) section or Common Technical Document (CTD) Module 3 of investigational and new drug applications (INDs & NDAs), abbreviated drug applications (ANDAs) and biologics license applications (BLAs). 
  • Write and review regulatory meeting package submissions for meetings with the FDA.
  • Provide advice on responses to FDA microbiology information requests and deficiencies.
  • Advise on post-approval filing approaches for changes impacting microbial control, sterility assurance and microbiological product quality. 

Regulatory Inspections
  • Review documents and systems, and prepare facilities for upcoming FDA inspections.
  • Prepare responses to FDA Form 483 observations regarding microbial control, sterility assurance, facility and equipment qualification, and quality systems.
  • Review and prepare responses to FDA warning letters.
  • Conduct audits.

Areas of Expertise
  • Regulatory Affairs & Compliance
  • Quality Assurance and Quality Control 
  • Aseptic Processing and Sterilization
  • Biotechnology
  • Biosimilars
  • Validation protocols and reports
  • Standard Operating Procedures (SOPs)
  • Microbiological process controls
  • Microbiological product quality and method qualification