Marketing Authorisation Applications (MAAs) for medicinal products require both expertise and diligence to ensure that the requirements of the European Medicines Agency (EMA) and the national EU competent authorities are met.
It includes development of strategy and planning, and the evaluation and review of documentation to ensure that your regulatory strategy is successfully executed.
When it comes to Marketing Authorisation Applications (MAAs), we have many years of experience in preparing quality, non-clinical and clinical documentation, and submitting applications in eCTD format in the decentralised procedure, the mutual recognition procedure, and national procedures.
Good news on search tips. Are you challenged when searching for specific information on the European Medicines Agency’s (EMA) website? You are not alone. By Lotte Gam Kristensen and Julie Lilholm The EMA website has [...]