Marketing Authorization Applications.
We’ve got the answers for your MAA.
What type of product do I have?
What type of change must I perform?
When do I need to make my submission?
Which documents do I need to support my submission?
When should I implement and launch?
These are just few of the questions MAHs need to deal with and our consultant experts are ready to advise and support you with all the answers, and the right type of procedure and legal basis considering:
- Type of product.
- Countries of interest.
- Time for approval.
- Cost effectiveness.
Our team offers support at each step, from taking care of administrative actions like slots/appointments booking, fee payments, to fulfilling local requirements on national portals, and through to your successful approval by ensuring the submission and validation of all procedures is done right, first time.
Our deep experience at both the global and local levels, and understanding and communication with National Competent Authorities during your procedure’s assessment, drives faster approvals for all your projects.
Regulatory affairs case studies.
View allMedical writing, Non-clinical modules, Gap analysis
Automation, Process improvement
Gap analysis, Submission strategy, Local liaison
