Regulatory Affairs

As response to the increasing complexity and competiveness of the global pharmaceutical industries and medical environment, our company has developed personalized Regulatory Affairs Services for successfully dealing with the challenges of operating in a rapidly changing world, tailored to meet the needs of modern medical and pharmaceutical companies and executed by qualified personnel with more than 15 years of experience in the pharmaceutical and health care domain:

• Marketing Authorization of pharmaceutical products for the Romanian market through EU centralized, mutual recognition and Romanian national procedures (for pharmaceuticals manufactured outside EU);
• Periodical renewal of Marketing Authorization for pharmaceutical products;
• Registration of Variations to already authorized medicines;
• Mandatory registration of prices with the MOH and joining in the National Reimbursement Program or various Special National Reimbursement Programs (Cancer, Diabetes, ATI, etc.) with the NIH;
• Mandatory periodical reports to RMS, MOH;
• Consultancy in creation, implementation and harmonization of international / local GMP, GDP procedures;
• Registration services for medical devices and equipment, food supplements, disinfectants, biocides;
• Business Development: intermediation of import and distribution contracts for pharmaceuticals and medical devices;
• Local representation: interactions on behalf of the Principal with the Romanian State Agencies, MOH, NIH, dealers, service providers, organization of clinical trials for medicines and medical devices.