Medicinal Product Lifecycle Maintenance
Medicinal product lifecycle management is defined as the process of managing the entire lifecycle of the product.
This includes its clinical development, marketing authorization and post-authorization activities. As medicinal products that are already marketed change over time, expertise in renewals, variations, and other medicinal product lifecycle management activities is one of the key elements to reach the company’s business goals.
Our experienced regulatory affairs team provides medicinal product lifecycle management services to our clients and offers solutions according to the scope and extent of your project.
Full Lifecycle Management Service
Biomapas full-scope product lifecycle management services include:
- Marketing authorization renewal management;
- Variation management (type IA, IB, II);
- Labelling support;
- Non-EU dossier changes/modifications/amendments;
- Product line extensions;
- Product status change (Rx/OTC);
- Sunset Clause management;
- Advertising and promotional material review.
All Post-Authorization Services
Ensuring regulatory compliance.