Consulting on regulatory affairs
Biotechnological products related to human or animal health must meet a series of regulatory requirements in accordance with the legislation in force in each territory and based on the type of product that is being developed.
Sometimes it is only necessary to carry out bureaucratic procedures with regulatory agencies, but in most cases animal studies as well as clinical trials must be carried out to corroborate the safety and efficacy of the products before they are launched on the market.
It is important to determine the applicable regulatory framework for each specific product, in order to develop a realistic project plan, in terms of time and cost.
In addition, in most cases, it is advisable to carry out scientific consultancies with the competent regulatory agency of the territory where we want to register our product, and in the case of drugs aimed at rare diseases, we must request the orphan drug designation as soon as possible.
Strategic consulting in industrial property
Good management of research results is crucial to ensure their successful transfer to society.
The patentability strategy of a company does not only include the processing of patents applied for or the filing of new applications.
The writing and publication of papers, the management of know-how and the writing of new patents should be carried out taking into account the global strategy of the company under the supervision of someone who has knowledge of industrial property and who in turn knows the business plan from inside.
Prior to filing the patent application, we must ensure that our invention is new and inventive through a patentability study.
But once our invention is patented, it is even more important to check that the product we are developing is perfectly protected, which we can verify by evaluating our patent, and that the placing on the market of our product will not imply the infringement of other patents, through a study of freedom of operations.
We organize and give ad-hoc courses for companies and institutions on regulatory matters, patentability strategy, valuation of r & d & i projects, etc.
More information: http://www.kinrel.es/formacion/