Exploitant - Pharmaceutical Establishment
External Communications
Analysis of promotional and non-promotional communication of health products
Regulatory compliance (medicines and MDs)
- Qualification of marketing materials: promotional or non-promotional materials
- Regulatory validation of the content: environmental, institutional, promotional PM and GP channels/materials, training
- Documented risk analysis, risk scaling via an internal validation tool and risk minimization proposal
- Admissibility and presentation of clinical studies
- Tailormade support: analysis of a document or campaign, from regulatory validation to filing with ANSM
- Digitizing relations with healthcare professionals and the public: remote medical visits, e-events, social media, press, influencer, apps
- Regulatory optimization of communication strategies
Process audit
- Document audit and process application compliance
- Process optimization
- Audit of service providers
- Implementation and follow-up of the CAPA plan
Training courses for regulatory, medico-marketing or communication teams
- In-company training
- Regulatory and methodological reminders
- Personalized workshops with role-playing
- Training programme tailored to your needs
- Certified training organization
Promotional information charter (medicinal product and medical device)
Complete or partial internal audits on a targeted subsection
- Quality policy
- Training
- Ethics
- Pharmaceutical establishment Exploitant
- Manufacturer or distributor of MD
- Subcontractor
- Qualification of the service provider
Preparation for certification
- Implementing / reviewing processes
- Forming and coordinating the steering committee
- Practical transposition of the reference system (quality policy, indicators, etc.)
- Comprehensive project management
- Personalized support
Border activities consulting
- Scope of medical speech
- Activities of non-promotional field employees (MSL, KAM, etc.)
- Promotional and non-promotional activities
- Promotional and non-promotional events (congresses, symposiums, staff meetings…)
Further information
A team of experienced consultants who offer you a complete package: strategy, analysis of regulatory compliance up to filing. Custom-made training for your regulatory, medical marketing, communication teams is also possible.