Files

The SYNERLAB Group proposes various partnerships in the fields of pharmaceutical products and food supplements and develops new products for the licence agreements.

The SYNERLAB Group has access to human and technical resources that enable it to coordinate all stages in the development/production of new files. This work is based on known or unknown molecules, either in isolation or associated with others.

Development phases

Phases covered: definition of the formula, development of control methods and manufacturing of registration and launch batches.

Our Spanish site, for example, specialises in products requiring bioequivalence or clinical tests. ALCALÁ FARMAcoordinates the different stages with the assistance of Contract Research Organisations (CRO).

As a pharmaceutical establishment, we ensure that all product developments take place in our laboratories, which meet the requirements of GMP. Our ALCALÁ FARMA & PHARMASTER sites guarantee successful product launches at all times, in line with the specifications of the registration file.

Product portfolio

ALCALÁ FARMA mainly supplies products which treat the symptoms of coughs and colds (for adults and children). Other products used to combat pain, digestive problems and sleep disturbances are also included in this portfolio. A bibliographic file is created for each product. These files are drawn up in English in CTD format and can be registered in countries which fulfil the criteria of the European Union. They are accessible at all times if the customer wishes to conduct an audit. All the different products which vary in terms of their pharmaceutical form are developed internally by our scientific team. We also offer a wide range of food supplements.

In addition to documentation, we provide an exhaustive service, including RRAA assistance, for our customers. This service is available throughout the entire registration procedure, with the aim of granting market launch authorisation.

Local multinational firms work in cooperation with us and use our expertise for their well-known brands. Many of our formulae for over-the-counter products have already been successfully registered and launched.

Consult our list of PHARMACEUTICAL MASTER FILES

Portefolio Dossiers Pharma 2016

Consult our list of FOOD SUPPLEMENTS

Portefolio Compléments Alimentaires 2016