Damjana Sekernik

Quantum Chimica Global Regulatory Affairs and Research solutions Ltd.

Quantum Chimica is an European Contract Research Organization offering regulatory affairs services worldwide for medicinal products (prescription drugs and OTC), medical devices, food supplements and cosmetics. We have many years of experience in preparing CMC packages for CEP, DMF, ANDA and other applications within global regulatory environment. Our experience derives from very experienced and dedicated team of regulatory affairs managers, scientists and managers with in-depth knowledge of Regulatory affairs, Organic and Analytical Chemistry, Biochemistry and Genetics, Pharmacy, HR and Sales management. Our team of experts holds university and post-graduate degrees and is efficient, professional and goal-oriented. In addition we can help you set Pharmacovigilance system, vigilance system of Medical devices and/or cosmetovigilance system and act as your local representative for aforementioned systems. Quantum Chimica Ltd. can professionally represent your company on EU market as well as organize representation in other countries worldwide. Quantum Chimica Ltd. is also offering services from area of Chemicals Legislation in line with European Chemicals Agency (ECHA) requirements: Regulation REACH, Regulation GHS, Regulation PIC, Regulation of Persistent Organic Pollutants, Biocidal Product Regulation, Preparation of Safety Data Sheets, Storage of Chemicals, etc.