Following adoption by the CVMP and CHMP, the EMA has published for consultation a “Reflection paper on the dissolution specification for generic oral immediate release products” (Link).
Regulatory Outsourcing Options
Cyton’s dedicated regulatory procedures team can support you with: - Dossier preparation, submission & regulatory procedures - Regulatory intelligence and strategic planning - Life cycle management - Key person cover - Pharmacovigilance - Brexit support services
As of February 2021, Cyton and Triveritas became knoell, creating one animal health team based in the US, EU, China, and the UK.
Cyton.com will no longer be maintained, but you can continue to follow us at knoell.com