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:

 

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 help you in making decisions before importing or distributing a product by analysing the documentation that guarantees its safety and quality according to current regulations.

We present the report of sales of similar products in public health.
We identify the KOLs (Key Opinion Leaders) and present their conclusions about the product studied.

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

MDI Advisers will help you to solve your needs for the import and distribution of materials to combat COVID-19.

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 guidelines that you need to follow for the marketing of health products, biocides and cosmetics in Spain and Portugal 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 regulatory affairs.

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.

STUDY OF THE DOCUMENTATION OF SANITARY, BIOCIDAL AND COSMETIC PRODUCTS

We help you in making decisions before importing or distributing a product by analysing the documentation that guarantees its safety and quality according to current regulations.

MARKET RESEARCH FOR SANITARY PRODUCTS

We present the report of sales of similar products in public health.
We identify the KOLs (Key Opinion Leaders) and present their conclusions about the product studied.

 

QUALITY MANAGEMENT (GxP)

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

IMPORT AND DISTRIBUTION OF COVID-19 MATERIALS

MDI Advisers will help you to solve your needs for the import and distribution of materials to combat COVID-19.

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 guidelines that you need to follow for the marketing of health products, biocides and cosmetics in Spain and Portugal 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 regulatory affairs.

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