What We Do
Expert Development Advisement
Regulatory Specialists - Proven, Practical, Precise
E&L Experts - Providing Fully Integrated Solutions
Pharmxtrax is based on the simple principle of Better Science - Better Results. Our advice translates complex requirements into practical, executable actions. Our "Tell Us Once" mentality means that we take the time to fully understand the scope of your project from the outset. After which, you can rest assured that it will be completed with expert efficiency.
E&L Experts - Providing Fully Integrated Solutions
Regulatory Specialists - Proven, Practical, Precise
E&L Experts - Providing Fully Integrated Solutions
Our team has successfully supported hundreds of E&L studies covering a broad range of pharmaceutical packaging & delivery systems, manufacturing equipment and medical devices. Our experts have been integral in the structure of the current guidelines and regulations. We provide guidance, study design, program placement and management.
Regulatory Specialists - Proven, Practical, Precise
Regulatory Specialists - Proven, Practical, Precise
Regulatory Specialists - Proven, Practical, Precise
When seeking regulatory advice, clients often hear "Well, that depends". Whilst, understanding the possible scenarios and outcomes is important, it is critical that your advisor can confidently navigate the regulatory landscape expeditiously.
Our team has the expertise of successful regulatory inspections and filings to ensure your pathway to approval.
Key Information
Key Services
- Full E&L Study Design and Placement
- Complete Program Management
- Materials Risk Assessments
- Toxicology Risk Assessments
- Regulatory Filing Advisement
- Customized training programs
Upcoming Events
International Conference on Pharmaceutical Science and Drug Manufacturing
Toronto, Canada AUG 4, 2024
https://www.allconferencealert.com/event/1104670
PharmaED Microneedle & Intradermal Delivery Forum
Philadelphia SEP 17 - 18, 2024
Microneedle & Intradermal Delivery Forum 2024 – Pharma Ed Resources
Contract Pharma Conference, New Brunswick, NJ SEP 25 - 27, 2024
Contract Pharma Conference - Conference Contractpharma
PharmaED E&L West, La Jolla, CA NOV 6 - 7, 2024
Extractables & Leachables West 2024 – Pharma Ed Resources
PharmaED Pre-Filled Syringes & Injection Devices, La Jolla, CA DEC 4 - 5, 2024
Pre-filled Syringes & Injection Devices 2024 – Pharma Ed Resources
Latest News
Soon to be published by Elsevier - 3rd Edition of “Specifications of the Drug Substances and Products: Development and Validation of Analytical Methods” . James R. Scull Co-Author of Extractables and Leachables Chapter. Pre-order Available:
About Us
James R. Scull, PhD
President, Pharmxtrax
Dr. James Scull is the President of Pharmxtrax, which provides advisement services to navigate the development life cycle of pharmaceuticals, single-use manufacturing equipment and medical devices.
With more than 37 years of pharmaceutical and CRO industry experience, Dr. Scull has supported hundreds of clients in gaining regulatory approval of their products and devices. Specific areas of emphasis include E&L, nitrosamines and regulatory compliance.
Prior to founding Pharmxtrax, Dr. Scull served as Scientific Director for Element Life Sciences, VP of NSF Health Sciences, Co-owner & Executive Director of Pharmalytica Services, Outsourcing Director for Purdue Pharma and Principal Research Scientist for the Dupont Pharmaceutical Company. He holds a PhD in Analytical Chemistry from Villanova University.