Planning and Executing a product launch requires an intensive understanding of complicated regulatory frameworks and multiple regulatory bodies.
Medspero develops to launch their product and increase the chances of success. A powerful launch method need to component in specific marketplace needs and calls for compliance with all local regulatory requirements..Every product has its own unique set of challenges and opportunities that should be taken into consideration before it is introduced to the market. It also requires specific knowledge about the marketplace. A robust evaluation and comparison of the product and its benefits is essential to convince key opinion leaders, prescribers and hospitals. Thus, we will leverage our experience with national health agencies, healthcare industry and our own professional network of physicians and pharmacists
However the proper approach will assist you decide which markets provide the best benefits for your product. Our team of specialists know how to deal with product launches worldwide and assist you to obtain optimal achievement in bringing your product to market.
Medspero provides regulatory affairs services throughout all EU/EEA member states that are connected to product launch operations on a national level. We can assist you in implementing successful launch plans for pharmaceutical products and achieving regulatory compliance on the EU/EEA and local levels. Your path to success will be paved with our in-depth knowledge of intricate regulatory frameworks and national regulatory bodies
We can assist you in planning the launch of your product, providing advice on expected timelines, and anticipating potential pitfalls and risks that may cause delays. Our knowledge will assist you in achieving maximum success in bringing your product to market and patients.
- Product launch consultation on local regulatory requirements
- Labeling exclusions for products delivered in foreign packaging
- Adapting educational materials to local needs and receiving national authority clearance
- Compliance inspection and approval of promotional materials
- Review and approval of artwork, including 'blue-box' specifications and extra data
- Pricing request and local price acceptance
- Creating and submitting a dossier for marketing authorization applications
- To launch the product, collaborate with commercial, marketing, and logistics.
- Contact person for the Regulatory Agency during the process