When considering whether to outsource work to a CRO, there are a number of factors to assess, including the type of work that may be outsourced, regulatory considerations, and needs for the study.

When Is It Appropriate to Outsource Bioanalysis Work to a CRO?

CDMOs offer expertise and customization options for sponsors of orphan drugs.

Fostering Orphan Drugs

Demand for outsourced services of technical R&D activities is increasing.

Balancing Internal Focus Against External Capabilities

Topic

Susan Haigney is managing editor of BioPharm International, susan.haigney@ubm.com.

Articles

A thorough understanding of both regulatory requirements and study challenges can help develop and validate the appropriate methods for a bioanalytical study program.

Aiding Regulatory Submissions Through Robust Bioanalytical Studies

It is important to understand regulatory requirements and study challenges to develop and validate the appropriate methods for a bioanalytical study program at the clinical stage.

Robust Bioanalytical Studies Can Aid in Regulatory Submissions

Meg Rivers is the former senior editor for 

Experts divulge where the industry is outsourcing most frequently, when companies should outsource more, and when performing tasks in-house might be best.

Deciding Where to Outsource in Biopharma Development and Manufacturing

Automation of pharmaceutical packaging saves costs and time, say contract packagers.

Automating Packaging of Bio/Pharmaceuticals

Robert O. Williams III, PhD, is the division head and professor of molecular pharmaceutics and drug delivery at The University of Texas at Austin, College of Pharmacy; the Johnson & Johnson centennial chair in pharmacy at the University of Texas at Austin, College of Pharmacy; editor-in-chief of the AAPS PharmSciTech scientific journal; and the technology inventor/special advisor for TFF Pharmaceuticals.

How dry powder techniques can overcome limitations in biologics development and delivery to broaden routes of administration and global accessibility.

Improved Formulations to Enable Stable Delivery of Biologics

Kindeva’s acquisition of iPharma will increase the company’s inhalation formulation outsourcing capabilities.

Kindeva Drug Delivery Completes Acquisition of iPharma Labs

Avid Bioservices has expanded its viral vector development and manufacturing facility with the addition of analytical and process development suites.

Avid Bioservices Launches New Analytical and Process Development Suites at Viral Vector Facility

Following the acquisition by Altaris Capital Partners, Johnson Matthey Health has rebranded as Veranova.

Johnson Matthey Health Rebrands as Veranova

Feliza Mirasol is the science editor for 

One can use modeling methods to generate data and shorten development timelines in preclinical studies.

Adopting a Modeling Approach for Preclinical Studies

Having a clear clinical strategy early on can shave time off overall development projects.

Outsourcing

When Is It Appropriate to Outsource Bioanalysis Work to a CRO?

Fostering Orphan Drugs

Balancing Internal Focus Against External Capabilities