Understanding the medical product life cycle and mastering each of its activities are the guarantees of efficient and profitable marketing.
1- Pre-Submission Phase
In focusing your attention of what it is necessary to obtain the approval of your medicine from regulatory organisms and its refund by the health insurance companies, we help you optimize your development program and make you understand the requirements of authorities.
2- Submission Phase
While handling the set of application sheets or key regulatory elements, we ensure that your data are presented more effectively, aligned with the requirements of local regulatory organisms. This allows to ensure best possible chances to approve the application.
3- Evaluation Phase
Although the submission of your MAA request may seem the end of a long trip, this may be only the beginning of a long process.
You shall prepare with a proactive way all questions that may emanate from regulatory organisms and to answer and interact effectively with the DPM and the LNCM in a reasonable delay, which is essential to your application request in order to obtain the approval. We support you within all the phases of evaluation.
The phase of evaluation itself can be an extended process with raised questions and the interactions with the organisms that can prove to be essential there where your product can evolve in the future. ALLIANCE INFOMED accompanies you through the evaluation phase. We support you in the procedure management by ensuring putting in place a response and action strategies.
We can also help you in terms of labeling and by assist you providing proper responses.
4- Post Authorization Phase
One the product is approved and launched in the market, its value can be assessed. While checking that your product is managed by an efficient and skilled way, we accompany you and the patient in order to get the best performance from your product.
ALLIANCE INFOMED offers the best possible perspectives to ensure that your product remains on the market and may be effectively maintained after the approval. We accompany you within the production change, the introduction of new markets, the renewal and variations.