FDA Registered
503B Outsourcing Facility
Under new ownership with outside regulatory and compliance services provided by industry leading LDT Health Solutions.
What is ProRx?
Located in Exton, Pennsylvania, we are in close proximity to clinical centers, hospitals and pharmaceutical companies.
ProRx is an FDA registered cGMP facility with a focus to supply clinical trial materials and to meet the need for drugs on the FDA drug shortage list. We can also provide customized products and formulations for institutions and physician offices.
Our Mission
support drug shortage and clinical research materials.
Our Vision
ProRx strives to combine our knowledge of pharmaceutical compounding and experience with product requirements for clinical studies to provide high quality and cost effective products in a time-efficient manner.
Our team’s knowledge and experience with the regulatory requirements will allow us to become a partner in the successful completion of clinical trials.
Our Team
ProRx team consists of seasoned researchers with extensive experience in product development and formulation testing. The team consists of members from academia, pharmaceutical industry and pharmacists licensed in PA.
Products and Services
Pharmaceutical Testing
We offer full testing services for products from pharmacies, Investigational Drug Services (IDS) in hospitals and pharmaceutical companies.
Our services include the following:
- Formulation testing
- Certificate of analysis (COA)
- Stability testing
- Beyond Use Date (BUD) studies assignment
- Life-cycle extension.
Formulation Development
We have facility and expertise for a wide range of new product development, consulting for product development, clinical studies materials, materials for physician practices and pharmaceutical companies.
We can supply the following categories of products:
- Solid dosage forms (tablets, capsules and powders)
- Disperse Systems (gels, creams and lotions)
- Sterile products in vials, bags and pre-filled syringes
- Placebo for all products.
- We also have the capability to produce lipid-based formulations controlled release systems.
Clinical Supplies
Providing clinical supplies for phase I-IV is our core strength. We can provide sterile and non-sterile products including tablets, capsules, gels, creams, lotions, injectable, vials, pre-filled syringes, placebo, controlled and extended release formulations in any batch size. All our products are manufactured in compliance with USP specifications and USFDA cGMP requirements and comply with testing requirements for Beyond Use Date labeling.
Clinical Trial FDA Documentation
Our team is familiar with the information needed for the chemistry and formulation section of clinical trial documents. We can write full protocols for the supply section of clinical trial applications.
Products On Drug Shortage
We have facility and expertise for a wide range of new product development, consulting for product development, clinical studies materials, materials for physician practices and pharmaceutical companies.
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