Contract-Resource-Outsourcing-Feature-Articles

1. Combination Products 2.0: Applying The New FDA Regulations 1/20/2012
   Combination products, those that contain medical devices embedded with pharmaceutical or biologic components, have become a large and growing segment of the medical device market. Some analysts estimate they represent over 30% of all new product submissions to the FDA. By Steven Richter, Ph.D
2. White Paper: Q&A On Contract Manufacturing Trends 8/25/2011
   Increased obligations for written procedures, manufacturing operations, and quality control has forced nutritional organizations to invest a great deal of time and capital. The biggest challenge for contract manufacturers of dietary supplements is the requirement for full testing of all active dietary ingredients. By Dr. Jeffrey Reingold, Manager, Research & Development, Contract Pharmacal Corp.
3. What You Don't Know Can Hurt You 3/4/2010
   The pivotal trial failed,” said a senior pharma executive in private conversation. “I got the call on Friday. I was dumbstruck—given its success in earlier work I could hardly believe it.” This type of shock is all too typical. Late-stage disappointments in clinical development programs are common, and many times come as a complete surprise to everyone involved. By HealthDecisions
4. White Paper: What You Don't Know Can Hurt You 3/4/2010
   The pivotal trial failed,” said a senior pharma executive in private conversation. “I got the call on Friday. I was dumbstruck—given its success in earlier work I could hardly believe it.” This type of shock is all too typical. Late-stage disappointments in clinical development programs are common, and many times come as a complete surprise to everyone involved. By HealthDecisions
5. Q&A On Contract Manufacturing Trends 1/7/2009
   Increased obligations for written procedures, manufacturing operations, and quality control has forced nutritional organizations to invest a great deal of time and capital. The biggest challenge for contract manufacturers of dietary supplements is the requirement for full testing of all active dietary ingredients. By Dr. Jeffrey Reingold, Manager, Research & Development, Contract Pharmacal Corp.
6. Recent Options For Phase I Formulation Development And Clinical Trial Material Supply 8/14/2008
   Pharmaceutical companies are challenged with choosing a dosage form that will reach clinical studies quickly and that can be made using a cost-effective process. To meet the demands of early-stage development, contract research organizations can evaluate various dosage-form options. By Balaji V. Kadri, Xcelience