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Thanks to its extensive experience in the industry, Arafarma offers services in different areas.
Arafarma Group has in its business strategy the collaboration with different partners in pharmacological projects of different therapeutic areas, basing the relationship on the WIN-WIN rule.
Arafarma Group offers its experience in:
- Chemical, galenic and clinical research.
- Presentation and obtaining of patents.
- The industrialization capacity of the projects.
- Regulatory Affairs and registration approval experience.
We are specialized in offering research and / or contract manufacturing services, achieving the commercialization of innovative products with great expectations of success.
Arafarma’s manufacturing plant is made up of state-of-the-art facilities and tailor-made equipment.
It is integrated by:
1º) An area of chemical synthesis and another of fermentation of biotechnological processes for the production of raw materials.
2º) A pharmaceutical plant for the production of solid and semi-solid, oral and topical forms.
In addition to our internal production, we can offer manufacturing with batches of varying scale, whether pilot batches or industrial batches in order to favor the registration of products, including the necessary quality control and the corresponding quality assurance.
Among the manufactured pharmaceutical forms are: pellets, granules, tablets, effervescent tablets, capsules, single-dose sticks, liquids, suspensions, aerosols, gels, ointments, etc.
Our department of regulatory affairs is responsible for the presentation and follow-up of the records until their approval and their maintenance over time.
Quick and efficient management in the Regulatory Affairs area, supported by the competence of our specialists and by their experience in the areas of quality, clinical, manufacturing and registration of ethical, generic, advertising pharmaceutical specialties, health products, etc.
This department provides an agile and efficient solution for those specialized services that pharmaceutical laboratories demand, taking into account that each collaborative project represents a key process for our clients.
Arafarma Group offers in the field of Regulatory Affairs:
- Design of registration dossiers.
- Complete development of the registration of a pharmaceutical specialty (ethical, generic, advertising, etc.) both in the experimental part and in the documentary part.
- Preparation of the documentation for the registration dossier of the marketing authorization.
- Validation and presentation of the registration dossiers.
Arafarma Group considers the medical visit as essential to connect with the different specialist areas and present its products and news. At the same time, it also participates in the different pharmaceutical congresses and fairs that are held throughout the country to reach all professionals in the sector and to publicize the different launches that are carried out.
On the other hand, international development represents one of the expansion paths chosen by Arafarma Group for its growth and consolidation. The commercialization is carried out through strategic alliances at local level with licensees and expert distributors in each territory.
United Arab Emirates