June 15, 2017
The pharmaceutical outsourcing market is undergoing significant changes. WDPrx invests heavily in infrastructure and expertise to provide relevant services for pharmaceutical companies.
WDPrx business strategy focuses on the changing requirements of pharmaceutical companies and develops services to support the industry. Special attention must be paid to enable quality systems to stay ahead of regulator demands.
Pharmaceutical and dietary supplement manufacturers looking to reduce management layers and costs are increasingly searching for outsourcing partners with scale-up and commercial manufacturing capabilities. WDPrx offers an integrated platform so that one partner can be utilized instead of multiple service providers. This comprehensive range of end-to-end services reduces oversight requirements, simplifies the process, generates value and may increase speed to market.
Increased regulatory requirements and competition are compelling pharmaceutical companies to concentrate on late-phase drug development and marketing. CMO providers enable manufacturers to attend to core capabilities while achieving efficiencies. WDPrx is equipped to help maximize the value of the complete drug package, which consists of the compound itself, the drug-delivery system and the experience and trust resulting from successful collaborations.
WDPrx specializes in customized development, manufacture and packaging of oral solutions, liquid solutions, suspensions and semi-solids for Over-The-Counter, Prescription and Specialty Products including cosmetics, nutritional supplements and medical foods.
The end-to-end range of services includes research and development, materials procurement, qualification, pre-formulation, formulation, process development, optimization, analytical method development, pharmaceutical validation, registration batches, commercial production, stability studies and related procedures, primary and secondary labeling, packaging and fulfillment.
High standards at WDPrx are assured with Quality System/cGMP guidelines followed in all departments. The DEA licensed facility (Schedules II-V) operates with a Drug Establishment License for manufacturing and packaging of pharmaceutical drug products.
Proper documentation and timely filing are essential steps in manufacturing pharmaceuticals. Technicians at WDPrx specialize in development and support of INDs, NDAs and ANDAs.
All phases of regulatory compliance are pro-actively managed including Pre-Clinical, Phase I Clinical and Late-Stage Clinical Trial materials. WDPrx is licensed as a Medical Device Manufacturer (Topical).