Areas of expertise / About us
Human medicines

QualitecFarma® works with transnational, multinational and local pharmaceutical companies of recognized prestige in innovative, generic and OTC medicinal products.
We have also played a key role in the establishment of foreign investment in Spain through registering medicinal products for companies without presence in the country.

The goal is to promote the development of the sector with our contribution to the success of new business projects in Spain and the attraction of foreign capital through the authorization of medicinal products and other companies’ products.

Veterinary medicines

The regulatory activity in the veterinary field is also a vital support for companies in animal care and therapeutics.

QualitecFarma® contributes to the development of the veterinary pharmaceutical industry giving regulatory and strategic support. At present, the company participates in projects for the establishment of synergies and strategic alliances.

Medical Devices

Since 2004, Health Authorities has integrated in its structure the general subdirectorate for medical devices, and therefore, QualitecFarma® expands its activity by supporting the companies of this area. Nowadays, Health Authorities is the only Spanish organism notified by European Commission, with number 0318, for medical devices Directives.

QualitecFarma® has a specific department for the development of regulatory projects, application of marketing authorizations and CE-mark for medical devices before the notified organism. Nowadays, QualitecFarma® takes part in different qualification projects for auditing the quality systems of medical devices manufacturing and marketing companies.

Cosmetics

Since 2004, Health Authorities has integrated in its structure the general subdirectorate for medical devices, and therefore, QualitecFarma® expands its activity by supporting the companies of this area. Nowadays, Health Authorities is the only Spanish organism notified by European Commission, with number 0318, for medical devices Directives.

QualitecFarma® has a specific department for the development of regulatory projects, application of marketing authorizations and CE-mark for medical devices before the notified organism. Nowadays, QualitecFarma® takes part in different qualification projects for auditing the quality systems of medical devices manufacturing and marketing companies.

Food supplements

QualitecFarma® also develops its activity working with companies dealing with food supplements, dietetic products, novel foods, parapharmaceuticals, nutraceuticals and, in general, with products whose use and regulation is getting closer day after day to the rigid rules and regulations governing pharmaceutical products.



Technology moves forward faster than legislation and the strict regulations applied nowadays to all products for human use make it difficult for many companies to launch certain products when their classification is hampered by the technology applied. The compliance and unawareness of these legal requirements sometimes makes the commercial strategy and launch of some products find obstacles in the process.



QualitecFarma® we provide support to the companies for the registration, authorization and notification of placing on the market for products that, without being medicinal products or medical devices, or even cosmetic products, require very strict approaches of registration and approval for granting their authorization by the competent organisms.

We evaluate and study the possibilities of authorization and marketing for the products based on the applicable regulations, determining their legal viability.

Others

QualitecFarma® also develops its activity working with companies dealing with food supplements, dietetic products, novel foods, parapharmaceuticals, nutraceuticals and, in general, with products whose use and regulation is getting closer day after day to the rigid rules and regulations governing pharmaceutical products.



Technology moves forward faster than legislation and the strict regulations applied nowadays to all products for human use make it difficult for many companies to launch certain products when their classification is hampered by the technology applied. The compliance and unawareness of these legal requirements sometimes makes the commercial strategy and launch of some products find obstacles in the process.



QualitecFarma® we provide support to the companies for the registration, authorization and notification of placing on the market for products that, without being medicinal products or medical devices, or even cosmetic products, require very strict approaches of registration and approval for granting their authorization by the competent organisms.

We evaluate and study the possibilities of authorization and marketing for the products based on the applicable regulations, determining their legal viability.

We are focused on your projects and new ideas

We are a services company oriented to regulatory and strategic business development.
We focus on establishing long-term B2B relation providing a global support to our clients’ needs.

Our areas of work cover