Case Study: Expedited Ointment Project Timeline

Challenge

A customer came to our team at JHS to fill GMP (Good Manufacturing Practices) batches to submit a new drug (NDA) of an ophthalmic ointment within a highly expedited timeline. The customer needed two clinical batches and three registration batches within a timespan of 12 months.

The clinical batches, including API and placebo, needed to arrive within 7 months of quote signature, while the registration batches were due 12 months from the project start. This differs to the usual project timeline of 6 months for the first engineering (non-GMP) batch and 10–12 months for the generation of the first GMP batch.

Approach

Customer and subject matter experts teamed up in order to create an expedited timeline for the project. Together, JHS and the client found key items that could affect the timeline and addressed them with innovative solutions. Engaging the team led to the completion of all project milestones within the client’s requirements.