Fully characterizing the pharmaceutical product – manufacturing process development, product specifications, analytical and microbiological testing methods and shelf-life evaluation – is critical across the multiple facets of the pharmaceutical R&D lifecycle. Oftentimes, as a project moves from Phase I through to Phase III and into commercial readiness, the manufacturing process changes; analytical methodology improves; product specifications evolve into their final form – all of which need to be meticulously studied and documented. Oculos has been leading the CMC development for clients for many years, and are experts in ensuring this important part of the ophthalmic R&D process is in control.
Oculos brings our unique CMC expertise to our clients in the following ways:
- Manufacturing service provider evaluation and selection
- Process development plans/reports
- Product specification development/issuance
- Stability plan (accelerated/real time) to support regulatory expectations
- Technology transfer plans/protocols/reports
- Investigational material production and analysis to support clinical study needs
- Preparation of CMC regulatory submission documents
