BULREAL 2000
We represent a company with our long-time experience in the field of chemical-pharmaceutical industry and patent-legislation activity, we are extremely experienced in drawing up and translation of documentation for registration of pharmaceuticals.
We represent a middle ranked Bulgarian company founded in 1991. With our long-time experience in the field of chemical-pharmaceutical industry and patent-legislation activity, we are extremely experienced in drawing up documentation for registration of pharmaceuticals, translations of drug master files and technical literature. Within the frame of this activity we work with medical teams of pharmacologists, clinicians, specialists in statistical processing and validation of results, patent experts and professional translators - physicians, pharmacists and chemists. The company is managed by a certified chemist - TU Dresden, specialized in patent law at the Humboldt University of Berlin, a longtime specialist in the pharmaceutical industry and professional in written and simultaneous translations, a member of the Union of Translators in Bulgaria.
Our activity covers the following fields:
• Consultations ondrugs registration in Bulgaria, drawing up of documentations according to the requirements of the Bulgarian Law on Medicinal Products in NTA and CTD format as per the regulatory requirements, organization of pre-clinical, pharmacological and toxicological studies, organization of bioequivalence/bioavailability studies according to GCP requirements;
• Drawing up and adaptation of documentations to CTDformat:
- SmPC, labelling and package leaflets
- Nonclinical overviews;
- Clinical overviews;
- Nonclinical study reports;
- Clinical study reports;
• Written translations from and into all languages in the field of medicine, pharmacy, chemistry and biology;
• Simultaneous and consecutive translation from and intoall languages in the field of medicine, pharmacy, chemistry and biology – workshops, medicinal products presentations, courses and training on Good Manufacturing Practice-GMP, GCP, GLP, etc.;
• Organization of medical advertising with leading product managers and compilation and translation of flyers, leaflets, brochures and other information materials;
• Advice services related to trademarks and patent registration in the pharmaceutical field; drawing up of patent documents;
• Marketing research and mailing for the pharmaceutical markets.
The company is certified ISO - Nr S 000066 EN 15038-2006 from November, 7th, 2012
Manager: S. Mileva, Chemist TU Dresden,
Patent Specialist Humboldt University
Leading collaborators:
Dr. med.S. Sotirov
Dr. med. AnastasiaPapazian
Sabina Vladikin – office manager
BULREAL 2000 OOD - Your partner in pharmacy and medicine
1000 Sofia, Bulgaria, 6, Parchevich Str.
tel. +359 (02) 8511647, mob. +359 888 383 646. +359 882528545
e-mail: bulreal2000@ new-s.bg
