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Serialization For the Rest of Us – Small and Mid-Size Manufacturers Achieving Post-Deadline DSCSA Compliance

By: Angela Holley, Business Development Director, WDPrx – Woodfield Pharmaceutical, LLC Nearly half of pharmaceutical manufacturers responding to a 2018 survey conducted by the Healthcare Distribution Alliance, an industry trade group, stated their products would not be serialized before the November 2018 deadline for DSCSA compliance. The fact is, a large number of small to mid-size manufacturers continue to search for compliance solutions. For this segment, confusion about DSCSA pharmace...

Equipment and Ingredient Challenges with Scale-Up and Technology Transfer of Suspensions

Authors: Angela Holley, Business Development Director; WDPrx – Woodfield Pharmaceutical, LLC Robert A. Falconer, Principal Consultant; Falcon Pharma LLC   Pharmaceutical suspensions have been around since at least the time of the writing of the Old Testament when the prophet Isaiah recommended that a ‘lump of figs’ be spread on King Hezekiah’s boil. This may have been one of the first instances where problems inherent in the making of suspensions became apparent.  The monarch m...

Clinical Trial Supply Chain Management: Changing Without Delay

By Adam Runsdorf, WDPrx President SUPPLY CHAIN OLYMPICS Compare clinical trial supply chain management to an Olympic sport and ‘balance beam’ would be an appropriate choice.  Successful trials demand a blend of costs and benefits to achieve desired results. Effective clinical trial supply chains increase efficiency and reduce risk while remaining on budget.  This task is challenging within conventional clinical trial environments.  New technologies for trial management may create more dif...

Quality Factors Influencing Semi-Solid Manufacturing

This story appears in the January 2018 issue of Contract Pharma magazine. Read it here. QUALITY FACTORS INFLUENCING SEMI-SOLID MANUFACTURING Kalpen Patel, Research and Development Manager, WDPrx Angela Holley, Business Development Director, WDPrx Although the name suggests otherwise, manufacturing semi-solid pharmaceutical drug products cannot be done ‘half-way.’  The making of semi-solid dosage forms, including pastes, ointments, gels and creams, requires specialized production techniques ...

Contract Packaging Operations At The Center Of Transition To Serialization

A version of this story appeared in the June 2017 issue of Contract Pharma Magazine under the title “Adapt Or Die.” Adapt Or Die As companies within the pharmaceutical supply chain near the November 27, 2017 deadline for the most recent phase of DSCSA compliance, contract packaging operations with comprehensive serialization implementation programs will see their business increase due to the new requirements. A primary goal of the DSCSA is improving information transparency to minimi...