Softlex

Softlex is providing professional services in following areas : A. REGISTRATION OF MEDICINES, FOOD SUPPLEMENTS, MEDICAL DEVICES, BIOCIDES 1. Consultancy on Romanian regulatory environment and strategies related to medicinal products (human and veterinary), food supplements, medical devices, biocides, including comprehensive regulatory intelligence. Preparation of documents in compliance with the requirements of local regulations for registration of new products / renewal procedure. Submission of the application to competent authority, correspondence and follow-up with the authorities during procedure. Post-approval regulatory activities: transfer of Marketing Authorization, approval of packaging according to local and EU regulations, submission of variations and line extensions, renewals, submission of promotional materials, switch to OTC and all other regulatory activities. B. MARKET ACCESS 1. Pricing – preparation, submission of the files and obtaining official price order. Reimbursement – consultancy and submission of reimbursement applications. C. PHARMACOVIGILANCE We offer pharmacovigilance consultancy, including possibility of access EudraVigilance as certificated members of XEVMPD community. D. TRAINING Softlex offers training programs on european and Romanian pharmaceutical regulations tailored on the needs of pharma companies. You may want to write to us to discuss your specific requirements and can do this on: office@softlex.ro