Each company that develops its business activity in the sector of health products, IVD and biocides has its own particular needs. That is why we have created this personalized hourly consulting area to respond to:
PRODUCT IMPORT LICENSE
We prepare applications for import and distribution licenses for sanitary products, IVD, biocides for the Spanish, Portuguese and European markets.
Product´s import licenses
We draw up the SOPs (standard operating procedures) and process the application for the different licenses required (for health products, including IVD, biocides and cosmetics) by the AEMPS (Spanish Agency for Medicines and Health Products).
Distribution of sanitary products
We process the request for the authorization of distribution of products to the health authorities in the CCAA (Autonomous Communities).
We carry out the communication of placing on the market of SP (Sanitary products) to the AEMPS, for risk classes 2a 2b and 3.
We assist in the monitoring and traceability of a product by providing reports of market behaviour to its manufacturer.
IN REGULATORY MATTERS
We put our Regulatory Affairs department at your disposal to cover the needs of your company, thus solving any eventuality that may arise.
Specialized technical advice on Regulatory Affairs.
Lack of technical personnel due to business volume, sick leave or vacation.
Tell us about your project and we will help you with the steps to follow to market health products, biocides and cosmetics in Spanish, Portuguese or Latin American territory, in accordance with current community and local regulations.
How to approach the project?
Study of the documentation of medical devices, biocides and cosmetics
We help you make a decision before importing or distributing a product by analyzing the documentation to make sure it guarantees its safety and quality according to current regulations.
Market Assessment of medical devices and active pharmaceutical ingredients
Market revenue and potential estimation in public health (both in Spain and Portugal accounts for the bulk of all sales)
Identification of opinion leaders we interview to draw conclusions about the feasibility, suitability and safety of the product.
Overview of the disease to be treated with the medical device under study: State-of-the-art and gold standards in diagnosis and treatment in Spain and Portugal.
Direct sale. Design and development of sales & marketing organization through a distributor that is already dealing with complementary products for the treatment and diagnosis of the pathology to which the product under study is directed.
Clinical and observational studies