Tracking inventory, managing clinical trial protocols, and leveraging provider reach
When to start planning: up to 24 months prior to launch
The suite of services needed at this stage includes everything from access to targeted provider networks to temperature-controlled, time-sensitive storage and transportation logistics and knowledge of international customs.
With so many moving parts, having AmerisourceBergen as your one, integrated partner can make a big difference.
Supply chain planning and patient recruitment challenges
- Recruit eligible patient populations
- Build a logistics platform that can scale up and out
- Acquire comparator drugs for testing
- Transport products across borders
- Efficiently collect and analyze patient data
Regulatory services & Pharmacovigilance
To navigate your product through the complete regulatory approval process with the Food and Drug Administration (FDA) you need a partner with expertise in regulatory strategy, dossier authoring, submission preparation and lifecycle management integrated with expert publishing and quality assurance solutions.
You'll also need comprehensive pharmacovigilance and medical information services help ensure compliance with continually evolving regulatory requirements ensuring the highest quality of safety data collection and processing.
AmerisourceBergen provides services including agency interface, pre-submission strategy, product classification, label development, common technical document (CTD) writing or review, support through to authorization post-market lifecycle management, advertising review, regulatory intelligence, training and more.
Let’s work together to envision new paths to healthier futures around the world.
Explore the next phase in the commercialization journey
Additional Insights
