Post development, our dedicated and specialised Tech Transfer team seamlessly transitions products to approved Contract Manufacturing Organisations (CMOs), ensuring complete process integrity from R&D to commercial manufacturing. Our large, in-house Regulatory Affairs team prepares and files EU CTD dossiers directly with the respective agencies — covering Europe (EMA), Canada (Health Canada), Australia (TGA), and New Zealand (Medsafe) — ensuring high-quality, compliant submissions. Our senior Technical team maintains rigorous oversight of all CMO partners through frequent site audits, ensuring continuous EU GMP compliance at every manufacturing site.

Post approval, our specialised Supply Chain and PPIC team ensures timely manufacturing planning and supply of products, strictly in accordance with approved specifications and market commitments — enabling our clients to rely on a consistent, uninterrupted supply of high-quality generics.

To date, Omnicals Pharma has achieved 50+ product approvals, in Europe with 20+ products currently filed in Europe and an active pipeline of 25+ products under development for Europe reflecting our end-to-end capabilities across development, regulatory, manufacturing, and supply chain.