serving the pharmaceutical & related industries
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.
Currently, Lifecells is conducting a clinical trial to assess the safety and efficacy of intra-arterial infusion and intramuscular injection of an autologous, bone marrow-derived stem cell preparation.
Services
- Cellular and Tissue Products Research and Regulatory Assistance
- Clinical and Bioequivalence Testing
- Design, Construction and Qualification of Facilities
- Drug and Biologics Licensing
- Drug, Device and Biologics Applications
- Formulation and Product Development
- Marketing and Sales Related Regulatory Assistance
- Operations Management Services
- Pharmaceutical Manufacturing Assistance
- Preclinical and Animal Pharmacokinetics
- Regulatory Assistance & Quality Assurance Audits
- Site Quality Services
- Sourcing Active Pharmaceutical and Other Ingredients
- US Agent and Advisory
