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Regulatory Affairs International

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The main services offered by DR International and aimed at an international requirement are:

  • Ability to establish contacts with companies, institutions and organizations working in Italy and in other European or non-European countries in the field of regulatory affairs;
  • Knowledge of European regulations in the field of medicinal products for human and veterinary use, biocides, cosmetics products, dietary supplements and medical devices;
  • Knowledge of the principal current regulations in certain non- EU countries;
  • Contacts with many local and international regulatory consultancy agencies;
  • Technical translations in the main languages ​​carried out by experts in the field;
  • Ability to submit requests for authorizations in Italy, Europe and other countries;
  • Ability to travel for audits of manufacturers of raw materials and finished products, in any country;
  • Detailed review of technical contracts, SDEAs and agreements between various companies.
Drug Regulatory Services

In order to obtain marketing authorizations for medicinal products for human and veterinary use in countries belonging to the European Union and the post-marketing regulatory management, it is necessary to implement specific regulations and guidelines that apply at a European level.

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Medical devices

In the European Union the marketing of medical devices is regulated by European standards. A medical device, once it has obtained the CE mark in a European country, can move freely in other European countries.

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Supplement Food

Although the European Community has issued a series of regulations and directives aimed at harmonizing the field of nutritional supplements and dietary products, in Europe the national laws are still the benchmark on account of their peculiarities and differences.

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Biocides consulting

Biocides are currently regulated at an EU level by EC Regulation no. 528/2012, with procedures, requirements and arrangements for obtaining marketing authorizations.

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Cosmetics Consulting

The entry into force of EC Regulation no. 1223/2009 concerning the placing on the market of cosmetic products has standardized and harmonized regulations for the sector at a European level.

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