Cellular and Tissue Products Research and Regulatory Assistance

PTS Consulting Global Services can provide any advisory or pharmaceutical consulting services from establishment to facilities, product plans and FDA regulatory assistance.

PTS Consulting Global Services and its partner company, Lifecells, LLC specializes in the development of cellular therapies for the treatment of diseases and conditions that impact tens of millions of people worldwide. The company applies stem cell-based technologies for adult stem cells and stem cells, along with other proprietary methods in the field of regenerative medicine to bring patient-specific therapies from the lab bench to the bedside.

Our CEO, Paul Sudhakar is involved in the investigational research in a clinical trial using the patient’s own stem cells to assess the efficacy and safety of a for patients with advanced Critical Limb Ischemia.PTS Global Services’ partner company, Lifecells, LLC specializes in the development of cellular therapies for the treatment of diseases and conditions that impact tens of millions of people worldwide.

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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