Services



  1. REGISTRATION OF MEDICINES, FOOD SUPPLEMENTS, MEDICAL DEVICES

    1. Consultancy on Romanian regulatory environment and strategies related to medicines, food supplements, medical devices, including comprehensive regulatory intelligence.

    2. Preparation of documents in compliance with the requirements of local regulations for registration of new products / renewal procedure.

    3. Submission of the application to competent authority, correspondence and follow-up with the authorities during procedure.

    4. 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.

  2. MARKET ACCESS

    1. Pricing – preparation, submission of the files and obtaining official price order.

    2. Reimbursement – consultancy and submission of reimbursement applications.

  3. PHARMACOVIGILANCE

    Pharmacovigilance is these days on the desk of every pharma employee, from MedRep to CEO as an activity of crucial importance. In the light of recent EU regulations, Pharmacovigilance activities, including reporting via EudraVigilance would need a careful assessment and step wise approaching to the duties every MAH needs to perform.
    We offer pharmacovigilance consultancy, including possibility of access EudraVigilance as certificated members of XEVMPD community.

  4. REGULATORY TRAINING

    As a result of extensive theoretical knowledge and applied regulatory practice, Softlex offers training programs on european and Romanian pharmaceutical regulations tailored on the needs of pharma companies.



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