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Last Updated Saturday, April 18 2015


Case Studies

March 3, 2015
The analytical method transfer is regulatory requirement number one.  Read More »
March 3, 2015
5 Key Considerations for Choosing a Pharmaceutical Contract Manufacturing Facility  Read More »
March 2, 2015
Many of the pharmaceutical companies we work withcontact us with questions about scaling up the manufacturing process.  Read More »
February 4, 2015
SUPAC Guidelines and Regulatory Strategy  Read More »
February 3, 2015
A common question for pharmaceutical companies using high shear granulation and fluid bed drying processes  Read More »
January 15, 2015
The Opportunity Teamwork amongst Reed-Lane employees is a primary mandate of the President of Reed-Lane. She realized that the company had two separate groups within it: the “office staff” who handled Reed-Lane’s corporate du…  Read More »
January 15, 2015
In a perfect world, every project runs smoothly and all components and bulk are ready at the same time to be packaged. But in the real world, that’s not always possible, and that’s why it’s important to have a packaging partner w…  Read More »
January 15, 2015
At Reed-Lane, every employee is dedicated to doing whatever it takes to make a client’s project a success. Here’s a story of what happened when Carmine Sodora, the Controller/Accounting of Reed-Lane, helped out on a project, and ended…  Read More »
February 6, 2014
With a focus on improving outcomes for patients, Norwich discovered a content uniformity issue during the technical transfer of a low dose product and then provided a novel solution to ensure reliable product supply. Through physical testing, it was…  Read More »
February 5, 2014
Norwich focuses on manufacturing potent, solid dose products, including fast dissolve and controlled release tablets, while also providing a range of analytical services in-house. To survive in a highly competitive marketplace, all contract manufact…  Read More »
February 4, 2014
Norwich's expertise in granulation processes was proven when a customer brought forth a product with a deadline for a Phase III clinical trial, but had no reliable scale-up process in-place to consistently produce robust tablets with the desired…  Read More »
May 20, 2013
A framework for donor and recipient companies to jointly analyze and document the technical and business risks associated with a technical transfer To help drive the tech transfer of partner products, Alkermes sought to develop a risk assessment fra…  Read More »
May 20, 2013
Alkermes’ successful approach to commercialscal final dosage manufacture of drug product containing highly potent API Project History • Donor site capacity issue where the company was seeking an outsourcing manufacturing partner for comme…  Read More »
May 20, 2013
Summary The successful transfer of a low solubility compound into one of Alkermes manufacturing sites achieving as a result, an OTIF (On-Time-In-Full) consistently over 95%.…  Read More »
May 20, 2013
Summary A large pharmaceutical contract manufacturing engagement demonstrating five years trouble free supply with OTIF (On-Time-In-Full) consistently >95%. Process and product improvement initiatives were also delivered, which enabled significant…  Read More »

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