Outsourced Pharma White Papers
Understanding FDA Guidance For Pediatric Oncology Studies
Learn how the Research to Accelerate Cures and Equity (RACE) for Children Act aims to improve and expand treatment options for pediatric cancer patients.
Making The Right Decisions Upstream To Ensure Downstream Success
Explore the latest strategies and technologies to develop a comprehensive, optimal approach to assay development and product characterization.
Switching Delivery Formats: A Lifecycle Management Strategy For Sterile Injectables
Switching delivery formats can be an effective strategy to enhance the lifecycle of your drug. Gain insight into the benefits and challenges of transferring a therapeutic compound from one aseptic injectable format to another.
Components Of An Effective Disinfectant Prequalification Strategy
Cleaning procedures designed specifically to destroy microbial contaminants that may be present are an important component of any microbial control strategy.
Tech Transfers: Optimize Success And Mitigating Risk
Gain direction for ensuring successful technology transfers by understanding how to identify common challenges and find case-based solutions and best practices for overcoming them.
Assessing End-To-End Drug Development Partnerships
As drug development becomes increasingly expensive and complex, pharma companies are relying on CDMOs. Consider the opportunities and challenges of end-to-end arrangements.
Taking Charge Of Your Stability Program
Learn how consolidating stability testing with a single partner offers improved efficiency, reduced risk, and more.
Rational Design And Development Of Long-Acting Injectable Dosage Forms
The increasing prevalence of chronic disorders, growing demand for self-administration, and the increasing demand for minimally invasive surgeries have fueled the growth of the LAI drug delivery market.
Innovative Formulation Technologies By 505(b)(2) Regulatory Pathway
Revitalization of older marketed drugs using innovative drug delivery technologies can provide new marketing exclusivity and patent protection, offering an effective tool for product life cycle management.
Are End-To-End CDMO Partnerships The Solution To Drug Development And Manufacturing Upheaval?
Growing complexity and risks in drug development and supply have implications for outsourcing models. See how to structure and manage CDMO partnerships for a future with uncertainty and disruption.