serving the pharmaceutical & related industries

Pharmaceutical Consulting


Pharmaceutical Development

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



Pharmaceutical Application Processing

Filing and Managing all of the Processes for FDA Drug Applications



Pharmaceutical Compliance

FDA and Global Regulatory Compliance and Submission



Pharmaceutical Manufacturing

Complete Facilities Design from inception to full FDA qualification


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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