CMC & Clinical Trials

On-Bir supports pharmaceutical finished product development with a scientist-led team that designs formulations, control strategies and complete CMC documentation (CTD Module 3) for Turkey, EU and regional pathways. We tie development decisions to EU-GMP expectations, supplier capability and tech-transfer practicality from day one.

On-Bir supports food supplement finished product development with a scientist-led team that designs formulations for targeted needs and complete regulatory documentation for Turkey, EU and regional pathways. We tie development decisions to market expectations and new trends, ensuring the product you develop is the product you can manufacture and supply.

On-Bir coordinates clinical trials (Phase I–III) with CRO partners while keeping the programme anchored to regulatory strategy, CMC documentation and EU-GMP quality expectations. Our scientist-led team adds protocol-to-submission thinking: feasibility aligned with target markets, data needs and eventual lifecycle changes.

On-Bir manages bioequivalence study and bioavailability study programmes as part of an integrated path to approval—linking BE/BA design to CMC documentation and Turkey/EU regulatory submission strategy. Our scientist-led team ensures study outputs map cleanly to CTD expectations, quality evidence and EU-GMP supply realities.