08.09.24 -- FDA Finalizes Guidance About Delaying, Denying, Limiting, Or Refusing An Inspection

What's your development and manufacturing outsourcing strategy based on? Do you have the right contracts and external relationships in place to successfully implement that strategy? Are there new models for sponsor-CDMO partnerships? Join Outsourced Pharma Live on August 13th as our panel of professionals will provide personal analysis and ideas for determining how you might best conduct your development and manufacturing activities, outsourcing business models, and external relationships.

Are relevant Drug Master Files (DMFs) at your CDMO in good order or fully under consideration as part of your upcoming new-drug submissions to the FDA or other agencies? “I've lived with this on both sides, as an FDA official and at biopharma organizations,” says Ben Stevens, Director CMC Policy and Advocacy, GSK, and former Branch Chief / Chemistry Reviewer at FDA. Here's what he advises.

Drive excellence in clinical trials by utilizing forecasting to better plan clinical supply budgets, project timelines, and identify potential supply-related issues before they negatively impact a study.

Any errors during the fill-finish stage can delay trials or even prevent meeting funding milestones. Be sure to avoid these common pitfalls when outsourcing your fill-finish project.

Choosing the right packaging partner for your probiotic may be the most crucial step to ensuring your product is safe and potent when it reaches the consumer.

Explore solutions to common quality, market demand, supply, and international manufacturing challenges faced when bringing new therapeutics to market.

A CDMO that leverages a multidisciplinary team approach can help you achieve effective scale-up production, handle potent compounds, and ensure regulatory compliance.

Our network currently spans across 9 manufacturing sites in 5 countries and can support discovery, preclinical, clinical and commercial programs for New Chemical Entities (NCEs).

We have defined work flows to assess and select solid forms in a cost and time efficient manner that meets the needs of each individual program.