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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Development

 Pharmaceutical consulting in product development activities including development support activities including but not limited to, preclinical, clinical, bioequivalence studies, chemistry & manufacturing controls and filing/approval of drug applications.

PTS has worked with many foreign firms in North America, Europe and Asia over the years and has successfully brought some of the firms in these regions into US FDA compliance and also assisted them in drug development and approval processes in USA.

PTS Pharmaceutical Consulting
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