Services offered by CMOs include, but are not limited to: pre-formulation, formulation development, stability studies, method development, pre-clinical and Phase I clinical trial materials, late-stage clinical trial materials, formal stability, scale-up, registration batches and commercial production.
The advantages in outsourcing to a CMO allows the pharmaceutical client to expand its technical resources without increased overhead. The client can then manage its internal resources and costs by focusing on its core competencies and high-value projects while reducing or not adding infrastructure or technical staff. Virtual and specialty pharmaceutical companies are particularly well-suited to CMO partnerships, and big pharmaceutical companies are beginning to view relationships with CMOs as strategic rather than tactical.
Working with a CMO also limits a client’s upfront capital investment for drug development, thus minimizing a project’s cost. By concentrating resources with a single-source provider, the outsourcing client can minimize technical transfer of projects or products, thereby reducing unforeseen costs and potentially speeding new products to market.
We can support in finding the right CMO’s matching your needs.
Or we can support in taking the first step: defining the Outsourcing Strategy for your product or project. There are many reasons to consider outsourcing your activities, e.g. :
- cost reduction
- time saving
- increase of productivity
- distribution of risks
- enhancement of management
- seeking innovation/expertise
- improvement of quality
The choice and reasons for a CMO/CRO/Supplier could be different during the various stages of product development. Qualification of the supplier will become more important towards clinical and commercial manufacturing. But also at managerial level of both the supplier and the customer, there should be a match. And of course the contracting part of the deal… Is timely supply guaranteed, can the supplier easily scale up if required, are all licenses granted…?
Have you performed a risk based analysis?
A sound manufacturing supply agreement and a quality agreement need to be in place.
Ar you confident in making the right choice? Did you perform a proper and sound comparison between suppliers?
RODI Connects can help you with your outsourcing strategy from A to Z.
For most companies, screening and optimization of manufacturing can result in a better, alternative and an affordable manufacturing plan. Growing business with a scalable approach. Based on material risk assessment & supply chain management. Lean manufacturing & control principles.