PTS Pharmaceutical Consulting
Over 30 years of experience in the pharmaceutical and related industries
PTS Consulting Global Services has been actively involved in pharmaceutical consulting, including product development and support activities including but not limited to, preclinical, clinical, bioequivalence studies, chemistry & manufacturing controls and filing/approval of drug applications. PTS Pharmaceutical Consulting Services is also involved in FDA review management of drug and biologic applications and approval/launch activities for numerous products some of which required circumventing of patents and exclusivities.
PTS Consulting has over 30 years of experience in pharmaceutical related industries, working with clients and governing bodies to prevent or resolve U.S. FDA compliance issues. We have extensive knowledge in pharmaceutical regulations and serve as the US agent and advisor for numerous pharmaceutical firms in the US, Canada, the European Union and Asia.
We're involved in the forefront of product development, analytical testing, manufacturing and clinical & pharmacokinetic testing of high quality off-patent pharmaceuticals. PTS consults on investigational research in a clinical trial using the patient's own stem cells to assess the efficacy and safety for patients with advanced Critical Limb Ischemia.
- Cellular and Tissue Products Research and Regulatory Assistance
- Clinical and Bioequivalence Testing
- Design, Construction and Qualification of Facilities
- Drug, Device and Biologics Applications
- Drug and Biologics Licensing
- Formulation and Product Development
- Marketing and Sales Related Regulatory Assistance
- Operations Management Services
- Pharmaceutical Manufacturing Assistance
- Preclinical and Animal Pharmacokinetics
- Regulatory Services and Quality Assurance Audits
- Site Quality Services
- Sourcing Active Pharmaceutical Ingredients and Other Ingredients
- US agent and Advisory
Filing and Managing all of the Processes for FDA Drug Applications
FDA and Global Regulatory Compliance and Submission
Complete Facilities Design from inception to full FDA qualification