serving the pharmaceutical & related industries

Pharmaceutical Consulting

Development

Pharmaceutical Development

INDs (Investigational New Drug) & ANDs (Abbreviated New Drugs)

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Application

Pharmaceutical Application Processing

Filing and Managing all of the Processes for FDA Drug Applications

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Compliance

Pharmaceutical Compliance

FDA and Global Regulatory Compliance and Submission

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Manufacturing

Pharmaceutical Manufacturing

Complete Facilities Design from inception to full FDA qualification

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Pharmaceutical Manufacturing Assistance

Facilities Design or Validation

Assisting organizations as they encounter facilities design, construction, or adaptation — or as they encounter facilities-related compliance problems. Through our powerful blend of compliance, regulatory, scientific, and technical expertise, we're highly effective in:

  • Analyzing, developing, and/or enhancing engineering requirements, specifications, and drawings, including HVAC, water, sterilization, and dust-control systems
  • Developing environmental and processing-room requirements
  • Recommending effective flow of materials, equipment, and personnel
  • Assessing and enhancing facilities requirements vis-à-vis manufacturing, assembly, packaging/labeling, and distribution operations
  • Addressing the facilities requirements of laboratory operations
  • Performing factory acceptance testing of equipment (FAT)
  • Conducting audits during construction and installation phases
  • Qualifying facilities for sterile, low-bioburden, and non-sterile products
  • Qualifying facilities for intermediates, APIs, and finished drug products
  • Qualifying facilities for medical device components and finished products
PTS Pharmaceutical Consulting
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