BCCI encourages the international endeavors of PharmaLex Bulgaria

During a meeting with the BCCI President Mr. Tsvetan Simeonov, the co-founder and co-owner of PharmaLex Bulgaria Dimitar Georgiev presented some of the strategic plans of the company for the near future. Among them he outlined the wish to establish business relations with producers of drugs, cosmetics and medical devices from the Balkan region.

Simeonov expressed his appreciation for such efforts and urged Georgiev to rely upon the international contacts of the Bulgarian Chamber of Commerce.

PharmaLex is one of the largest specialized providers of Development Consulting, Regulatory Affairs, Quality Management & Compliance and Pharmacovigilance, Epidemiology & Risk Management worldwide.

As part of the global reach and local presence PharmaLex Bulgaria team provides services for registration of drugs, medical devices and cosmetics as well as with pharmacovigilance. By combining the vast experience of its German partners along with the high-quality and unique skills of the Bulgarian specialists, PharmaLex supports pharma companies throughout the entire product lifecycle, ensuring compliance with pharmaceutical regulations and providing vital scientific and strategic advice on drug development. Its services extend beyond market approval and include product maintenance post launch activities.

PharmaLex has specialized in the safety of pharmaceutical and cosmetic products and can assist you in meeting the new EU requirements (The EU Regulation on cosmetic products (Regulation (EC 1223/2009). Its team of toxicologists, physicians, pharmacists and vigilance experts can support you with:

• Review of the current system and procedures and suggestion of necessary actions to comply with the new legislation
• Providing a compliant cosmetics products systems, including:

• Responsible person;
• Notification of the products in Cosmetic Products Notification Portal;
• Preparation and maintenance of Product information File;
• Cosmetovigilance, set up of a complete post-marketing surveillance of Serious Undesirable Effects;
• Reporting Serious Undesirable Effects to the Competent Authority
• Cosmetic products safety assessment;
• Preparation and maintenance of consumer information and product labeling.