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.

Pharamacutical Consulting

DEVELOPMENT

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

APPLICATION

Filing & Managing all of the Processes for FDA Drug Applications

COMPLIANCE

FDA and Global Regulatory Compliance and Submission

MANUFACTURING

Complete Facilities Design from inception to full FDA qualification

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