Business development & market access
Even the longest race must begin from where you stand
Regulatory activities are closely related to strategic bets, and therefore we expect to work together with companies in the decision-making process throughout the search for business opportunities starting from dossier development and up to strategic planning of international registration procedures till the launch of the medicine on the market.
We study, search, and select “partners” for our clients so as to establish synergies and strategic alliances. All in all, we pursue agreements that represent an improvement in the portfolio or in the turnover of the parts while trying to broaden the concept of licensing-in-out of a single product to the concept of strategic alliance between partners. Not only for the development of complete product lines but also for the establishment of joint ventures and manufacturing or distribution agreements among companies all over the world.
Securing these kinds of agreements represents for our organization the reason for and the result of a commitment with the sector as well as true career guidance for the professional staff that forms QualitecFarma®.
We take an active role throughout the value chain framework of medicines, starting from the raw data till we have the dossier in eCTD format; regulatory and scientific advice throughout the whole process before the dossier becomes approvable in different countries of the EU, MENA, USA, Asia etc.
With our organization and thanks to the experience and qualification of our team we can supply, readily available, the product you need in order to complete your portfolio, through licence brokerage (licensing-in-out) or complete development of new generics and OTC specialties.
Therefore, QualitecFarma® participates from the beginning up to the last stage in the search and selection of active ingredients and suppliers, submission, follow-up, and final granting of the Marketing Authorisation, according to the client’s needs.
Having evaluated commercial needs of our clients, we try to find the best solution possible to introduce their product on a new market in the most effective way.
Being specialists in this field we offer the following services: