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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Operations Management Services

With over 30 years of experience, PTS Pharmaceutical Consulting Global Services has obtained advanced knowledge of pharmaceutical manufacturing, validation, research and development processes.

Pharmaceuticals-Operations-ManagementA study of the operational practices of more than 25 global pharmaceutical manufacturers finds that top ones are more than twice as productive as their average counterparts. PTS assists our customers to ensure their facilities, equipment and processes make their operation as productive as possible.

We are skilled in the areas of quantitative systems analysis, planning and design of pharmaceutical process operations, and project management and implementation relative to all technology intensive operations.

This includes manufacturing operations, systems automation, packing and distribution, quality control and regulatory compliance, process and product validation, and supply chain management.

Turnkey Expertise

We have the pharmaceutical consulting expertise to provide complete turnkey services for virtual pharmaceutical companies, providing all services to take a product from the research and development stage to market.

PTS Global Services offers our manufacturing partners turnkey solutions:

  • Initial product identification and selection
  • Market, financial, regulatory, and legal analysis and due diligence for new product opportunities
  • cGMP-compliance oversight and gap analysis of manufacturing sites
  • ANDA preparation, submission, prosecution and interface with FDA
  • Regulatory services and support
  • Patent review/analysis
  • Paragraph IV litigation strategy and management
  • Sales, marketing, warehousing, and distribution

PTS Global Services can also assist in 3PL to handle all aspects of business operations, including; procurement, purchasing, inventory management, warehousing, distribution, transportation and customer service support, all while maintaining high service levels and superior customer satisfaction.

Contact PTS Global Services