We ensure maintenance and regulatory compliance of your registration through product life-cycle post-approval to ensure compliance, safety and optimal product maintenance
After Marketing Authorization granted, additional regulatory requirements must be considered throughout its lifecycle. These regulatory measures including variation and renewals are essential to ensure compliance, safety and successful marketing and use of the product.
AREMA team provides you maintenance services and support throughout product life-cycle post-approval including
- Management, preparation and submission of variations and renewals
- Coordination and communication with Health Authorities and management of requests and inquiries
- Maintenance of core dossiers for a portfolio of products
- Marketing Authorization Transfers or extension procedures
- Labelling management and revision
- Promotional material compliance and management of advertising visa applications.
- Samples dispatch and release procedure
- eCTD publishing and submissions activities
- Revision and submission of safety documents: PSURs, RMPs and ACOs
- Pharmacovigilance activities
Categories covered: Medicines and medical devices
Region: Africa, MENA, GCC, Europe
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