Services
EARLY ACCESS PROGRAM, MARKET ACCESS PUBLIC AFFAIRS
​​• Early Access Program / Market access / public affairs before getting Marketing authorization(MA) and after approval
​​
• Pricing and reimbursement, once MA granted: preparation and submission of medical & scientific dossier (NIT), Economic and pricing dossier (NIE with budget impact model …)
​
• Support on pricing negotiation with pricing committee (CEPS) including post marketing studies commitment…
• Public affairs support (meeting with HTA – HAS in France)​
EXPLOITANT STATUS FOR YOUR PRODUCTS (MEDIXAL)
Being your local pharmaceutical representative, we act as your official local point of contact with the Health authorities (ANSM, EMA, CEPS, HAS etc) regarding:
​
• Quality assurance: Quality management system: SOP, Deviation, CAPAs, change control, product quality matters, audit, inspection, quality review, vendors management, site master file handling.
​
• Batch follow up and recalls: stock monitoring, stock out declaration, Shortage management plan, serialization, returns goods.
​
• PV: oversight on local PV activities with the local PSMF.
• Medical Information: oversight and management on medical information activities, standard responses and FAQ validations.
• Product quality complaints management.
• Product information review and update including the SmPCs annexes review, packaging artworks approval.
• Submission of market access dossier.
​
• Promotional and non promotional communication management (ANSM submission for visa grant).
COMPLIANCE / LEGAL
(MEDIXAL)
The activities provided by Medixal are:
​
• Oversight of the sales reps activities linked to the Charter on information provided for the promotion of medicinal products through prospecting or canvassing and HAS referential regarding relationship with the HCP such as:
- Sales reps mandatory trainings and control: onboarding and follow up trainings for maintaining the qualification
- Monitoring of the reps operational activities: numbers of calls, quality of calls, respect of local access rules…
- Preparation of annual certification audit on promotional activities.
​
• LEA: benefits framework law – notification and submission dossier of financial relationships with HCP.
​
• Transparency- sunshine Act.
​
• MEDIXAL has the Certificate for the activity on information provided for the promotion of medicinal products through prospecting or canvassing according to the referential of HAS certification march 2017.
WAREHOUSING & LOGISTIC
MEDIXAL has set up an exclusive partnership with one of the main players in French logistics. This partnership enables us to keep the same contact for exploitation and logistics, while guaranteeing genuine specialisation in each of the 2 areas.
​
• LNB Logistique is a company specialising in the management and distribution of promotional material to sales forces, entertainers,
points of sale, seminars, trade fairs, conferences, etc.
​
• LNB Logistique is also a pharmaceutical establishment (depository / central purchasing office) specialising in logistics for healthcare professionals: regulated document logistics, distribution of healthcare products and medicines.
PROMOTIONAL / TRAININGS / SALES REPS THROUGH PHARMAFIELD
Pharmafield is the exclusive partner for the promotional and non promotional sales reps activities, and medical & scientific information.
​
• Information/sales, medical, pharmacy and scientific team dedicated for Pharma/Health company.
​​
• Recruitment agency specialized in Pharma/health company.
​
• Call Center
Phone and teleconference customer relations platform.
​​
• Omnichannel
Synergy of face-to-face and digital communication.
​
DATAFIELD
Health Data Strategy / Analysis.
​​
DOM PHARM
Leader in medical, pharmacy and scientific information/sales in the French overseas departments and territories (DROM COM).