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Stay Up to Date With All Developing News From WDPrx: January 2019

WDPrx – Woodfield Pharmaceutical, LLC is a proven and reliable CMO pharma partner specializing in oral solutions, liquid solutions, suspensions and semi-solids. We increase efficiency ‘from lab to launch’ managing early stage development, R+D, technology transfer, pharmaceutical formulation and development, exhibit batches, ANDA and NDA regulatory support.

 

Packaging and labeling equipment is programmed to print and read 2D barcodes.

Serialization Accomplished

The requirements for pharmaceutical serialization compliance were completed at WDPrx last year with time to spare before the FDA deadline of November 27, 2018.  Allocation of DSCSA-compliant serial numbers with track and trace protocols throughout packaging, labeling and EDI data transmissions are all performing to specifications for efficient and safe movement of medications within the supply chain.

 

 

 

Laboratory services support product development, testing and manufacture from early development to commercial production.

Product Development Projects Increasing

The on-site laboratories at WDPrx are accommodating an increasing quantity of client requests for early stage development including pharmaceutical formulation, stability testing, method development and pharmaceutical validation leading to production of exhibit batches. Manufacturers rely on WDPrx to perform a broad range of services to support their business strategies.

 

 

 

 

Cost control requires the same discipline shown by our laboratory technicians for successful technology transfer projects.

Technology Transfer Cost Control

Contract manufacturing partners are sensitive to cost pressures placed on manufacturers. Technology transfer costs are a key element to contain budgetary expenditures. WDPrx harnesses technology and equipment and stresses open communication to expedite projects to successful conclusion.

 

 

 

 

WDPrx supports clients with timely completion and submission of documentation to regulatory authorities.

Regulatory Focus

Along with a focus on product development, WDPrx continues to build regulatory compliance services at our Houston facility to ease pressure on manufacturer burn rates and to maintain relationships from early-to-late stage development.

 

 

 

 

 

Clear division of responsibilities and a pathway for dispute resolution help assure successful collaboration between manufacturers and CMO pharma partners.

Six Steps Pharmaceutical Manufacturers Should Follow For Successful CMO Projects

We refine successful partnerships between manufacturers and CMO pharma partners down to six simple steps. These steps include dispute resolution, division of responsibilities, changes requested outside the agreement terms, regulatory compliance filing requirements, logistics capabilities and business practices.