PHARMILLENNIUM CONSULTING D.O.O.
We are PharMillennium Consulting
The Directive 65/65 EEC was laid down 35 years ago, starting the new era in the pharmaceutical sector of the European Community. Since than, the regulatory authorities of the EU member states have invested a lot of efforts to develop contemporary, harmonized and effective regulatory background in the scope of pharmaceuticals in the EU. Strict regulations for the research and development of medicines for human use, for their manufacture, marketing, control, inspection, use, etc. influenced the changes of regulation in the other European countries, especially in those trying to achieve membership in the Community. Enforced by the activities and support of WHO and its bodies, these standards were given the global importance through their application and/or implementation in small and developing countries, worldwide. The International Conference on Harmonization of Technical Requirements for the Registration of Medicines for Human Use (ICH) is entering the new millennium after five Conferences and 10 years of progress. That became the global process of the development and implementation of the three key requirements for contemporary pharmaceutics - the quality, safety and efficacy of medicines.
The widening limits of knowledge and expertise required to develop, manufacture, market, prescribe and use medicines had introduced the necessity for the novel branch of the services - pharmaceutical consulting. Beside of the lot of the companies around the world servicing the pharmaceutical industry, regulatory authorities and international organizations, let us to present you the first consulting services and pharmaceutical experts private company in the Yugoslavia,
During the last ten years in Yugoslavia, domestic pharmaceutical sector encountered a lot of obstacles for the development and implementation of international standards. But, domestic companies were always among leading ones in the Central and Eastern European countries, thus meaning that such expertise gained has no expiry date and that it could serve as the basis for the successful development. Increasing importance of harmonization of domestic with international regulations in this scope, as well as exporting requirements for the domestic industry, which are influencing to enlarge needs for faster implementation of such regulations, are opening entrances for the pharmaceutical consulting services.
Having in mind all mentioned above, we decided to start the company Pharmillennium Consulting with the aim to share the fate in the pharmaceutical sector and to serve to the regulatory authorities and industry in order to achieve international standards for the letter common future.