PTS Pharmaceutical Consulting Global Expertise

PTS Consulting Global Services key fields of expertise range from preparation of drug, food and/or cosmetic facilities from inception to full FDA qualification and filing. Managing the processes for FDA drug applications especially Abbreviated New Drug Applications (ANDAs), INDs (Investigational new drug) and 505(b)(2) NDA and BLA applications.

PTS Global Services has over 30 years of experience in pharmaceutical consulting in the worldwide generic pharmaceutical market, we provide unparalleled experience across the value chain with extensive knowledge of drug development processes acquired through hands-on and didactic experience in all aspects of drug product development and problem solving, drug registration regulation and R&D activities.

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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