If you are considering using a CDMO, chances are you have a specific timeline in mind for your project.
- A breakdown of all of the documents that need to be completed by you (MSDS, Safety Assessments, Regulatory Statements, API Solubility, API Reference Standards, Potential Daily Exposure Documents).
- How to avoid materials issues in your formulation (API availability, finished product availability, special order materials, standard materials, capsule shells, tablet embossings, aesthetic coatings, dyes, API sensitivity issues).
- Background on the testing and studies process and how you can prepare for it (Hold times, extended stability, outsource testing requirements, excipient compatibility studies, excipient methods, CQAs and DOEs, discriminating dissolution methods).
- How to approach the manufacturing and packaging aspect (unique processes and previous equipment used, how to avoid sub-lotting. standard packaging components, desiccants, decisions on blister packaging, how to avoid cartoning, insert and label guidance, intent to commercialize in international markets, and aligning with a CDMO's standard operating procedures).
By accessing our guide, you receive over 70 years of drug manufacturing experience in the form of a checklist that you can use to make sure your formulation development project goes off without a hitch.
Choosing a CDMO that can help you avoid unnecessary errors in your important project while staying on your timeline and budget is a key part of the partnership. This guide helps you better understand how to keep your project moving as quickly and cost effectively as possible with whatever CDMO you end up choosing.
UPM has decades of experience providing services to clients at every stage of the development and commercialization process and take pride in providing strong communications throughout each project to ensure there are no last minute surprises to your budget or timeline.
