AC HELCOR Pharmaceutical Company invests annually important budgets for research and development of new forms of pharmaceuticals.
To keep up with the latest findings in the pharmaceutical field, product quality certification and management safety, all products placed on the market are subject to research and development studies carried out in the AC HELCOR Research & Development Center (C & D-P) in collaboration with independent centers or university-renowned and managed by pharmaceutical or medical professionals.
The rules to be followed in the process, are required by the European Community standards in the pharmaceutical industry.
The activity starts from setting the product parameters through preformulation studies – formulation, intellectual property, stability, validation, transfer to industrial scale, physicochemical, microbiological, clinical research, bioequivalence, pharmaceutical safety – pharmacovigilance, postmarketing studies, which attests the quality and effectiveness and therapeutic equivalence of the product in relation to the reference products in strict accordance with European and international regulatory standards.
Within the AC HELCOR Research & Development Center it were first developed in Romania in order to increase accesibility of the romanian patients to healthcare means:
- the extended release (ER) tablets – CORZEM 120 mg – patented formula
- the technology for film coating of the tablets – 1996.
- the packaging of medicines in blisters – 1996
- innovative formulations – 5 patents.
- the nationally-awarded pharmaceutical formula at the National Invention Salon 2007.
- the first GMP drug pilot research facility – scaling – 2000
- the manufacture of food supplements using standardized extracts to certain biologically active principles – 2004
- over 15 active substances from natural origin produced in Romania (first Romanian products)
- over 20 generic drugs produced for the first time in Romania (20 first Romanian generics)
AC Helocor Research & Development Center (C & D-P) conducts studies of:
- Preformulation and formulation studies. Pilot Research Center develops studies in biopharmacy, safety, clinical efficacy, quality and pharmaco-toxicological safety in collaboration with the most important university research units, the subject of a significant number of scientific papers, communicated at domestic and international events, published in profile magazines, doctoral projects, license, currently auctioning and running for a number of 8 projects in 2010 pharmaceutical research grant.
- Quality control – physical – chemical control, stability, validation, transfer to industrial scale
- Pharmacokinetic studies – bioavailability tests – in vitro and in vivo
- Clinical, pharmacological and toxicological studies – safety and efficacy of medicines and food supplements HELCOR – in partnership
- Documentation, patenting, protection of inventions and trademarks
- Pilot – scale up with homothetic series and GMP pilot series
AC HELCOR Research & Development Center is registered: