The extensive experience in various fields of the pharmaceutical sector in multicultural environments and the different position occupied in multinational companies (such as Johnson&Johnson, Boiron, Farmexpert) helped me to develop new skills, competencies, experience and expertise for:
Medicines Advertising & Regulatory Affairs.
Together with an extensive team of qualified experts, pharmacists, doctors and lawyers we offer assistance, consultancy services and advice for:
MARKETING REGISTRATION OF MEDICINAL PRODUCTS, COSMETICS, FOOD SUPPLEMENTS, MEDICAL DEVICES
Support for Marketing Authorization
Our services include strategic planning, regulatory wise, correlated with customer needs and market trends and synchronized with the planning of launching new products on the market. We offer a full range of pre and post-authorization services, document tracking and communication with authorities:
the submission of authorization dossiers for national authorization procedures
completing the MRP/ DCP national phase
translation and adaptation of the local label and leaflet in accordance with the relevant local requirements
post-marketing surveillance and support: variations, renewal, change of the status of the medicinal product, transfers of the marketing authorization owner, approval of the packaging materials according to national and European regulations, submission of promotional materials
Advice and assistance in authorization/ notification procedures for advertising materials , promotional materials, educational materials, direct communication with health professionals.
REGULATORY AFFAIRS TRAINING & COACHING PROGRAMS
We organize one/two days courses for pharma industry needs. These are introductory or advanced courses on Regulatory Affairs for Medicines, Cosmetics and Food Supplements, Pharmacovigilance and Clinical Trials.
One day courses are aimed to non-experienced participants, students and people from related fields, such as a marketing and sales for the broad overview and understanding of the pharmaceutical processes and procedures. Contact us for more details.
Prices and reimbursement of medicines: consultancy and filling the application for reimbursement
Advise & Counseling on pricing issues and local regulations, avoiding the traps of national systems.
Translation of all related documents
Follow-up and communication with experts and administrative supports at all levels
Support and advice on Pharmacovigilance, local QQPV and access to EudraVigilance.
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