TAILORED CONSULTING

Each company that develops its business activity in health technology, IVD, biocides and cosmetics sector has its own particular needs.
This is why we have created this customized consulting area to provide answers to:

 

Development and implementation of quality systems for health products, biocides and cosmetics.
Quality assurance system evaluation audits:

   Routine audits
   Pre-inspection audits

Support in the correction of non-conformities detected in inspections, withdrawals and claims.
Initial and continuous training for company personnel involved in the correct application

We prepare the applications for import and distribution licenses for health products, IVD, biocides and cosmetics.

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.

We put our Regulatory Affairs department at your disposal to cover the needs of your company, thus solving any eventuality that may arise. Such as:
Lack of technical staff, sick leave or holidays.

Tell us about your project and we will help you with the steps to follow for the commercialization of medical devices, biocides and cosmetics in the Spanish and Portuguese territory, in accordance with current European and local regulations.

Our goal is for you to spend your time generating revenue through import and distribution while MDI handles the paperwork.

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.

Competition analysis.

•  Sales channel

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

QUALITY MANAGEMENT (qms)

Development and implementation of quality systems for health products, biocides and cosmetics.
Quality assurance system evaluation audits:

   Routine audits
   Pre-inspection audits

Support in the correction of non-conformities detected in inspections, withdrawals and claims.
Initial and continuous training for company personnel involved in the correct application

PRODUCT´S IMPORT LICENSE

We prepare the applications for import and distribution licenses for health products, IVD, biocides and cosmetics.

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.

TECHNICAL STAFF 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. Such as:
Lack of technical staff, sick leave or holidays.

 

PROJECT DEVELOPMENT

Tell us about your project and we will help you with the steps to follow for the commercialization of medical devices, biocides and cosmetics in the Spanish and Portuguese territory, in accordance with current European and local regulations.

Our goal is for you to spend your time generating revenue through import and distribution while MDI handles the paperwork.

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.

Competition analysis.

•  Sales channel

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