Pharma Consulting

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.
  • Pharmacovigilance
  • Clinical studies
  • Cosmetics& biocides
  • Food supplements
  • Medical devices

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.

MARKET ACCESS  

            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

PHARMACOVIGILANCE    

Support and advice on Pharmacovigilance, local QQPV and access to EudraVigilance.

TESTIMONIAL

Consultanţă în piața farma

Am lucrat cu Roxana în cadrul unei campanii de constientizare într-un grup de lucru al ARPIM. Am rezonat imediat şi am apreciat la ea faptul ca este un specialist cu o viziune cuprinzătoare, foarte implicată în toate proiectele şi foarte bine documentată. Inţelege şi cunoaşte foarte bine piaţa farmaceutică, se documenteaza in amanunt şi astfel feedback-ul venit din partea ei este foarte relevant. Analizează toate datele, ascultă toate părerile, înţelege implicaţiile şi vine cu soluţii creative şi pline de conţinut valoros. Este un profesionist cu care voi lucra în continuare şi pe care îl apreciez dincolo de professionalism, ca şi om.

Florina Badea – CEO HealthConections, Blogger, Health Coach – florinabadea.ro

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2017-10-09T15:35:09+03:00

Florina Badea – CEO HealthConections, Blogger, Health Coach – florinabadea.ro

Am lucrat cu Roxana în cadrul unei campanii de constientizare într-un grup de lucru al ARPIM. Am rezonat imediat şi am apreciat la ea faptul ca este un specialist cu o viziune cuprinzătoare, foarte implicată în toate proiectele şi foarte bine documentată. Inţelege şi cunoaşte foarte bine piaţa farmaceutică, se documenteaza in amanunt şi astfel feedback-ul venit din partea ei este foarte relevant. Analizează toate datele, ascultă toate părerile, înţelege implicaţiile şi vine cu soluţii creative şi pline de conţinut valoros. Este un profesionist cu care voi lucra în continuare şi pe care îl apreciez dincolo de professionalism, ca şi om.
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