Working with its clients to ensure a successful outcome in terms of market access, Grove consultants based in Bulgaria provide expert advice in three key areas:
- Pricing and reimbursement
- Pharma compliance, pharma quality assurance
- Regulatory affairs (RA) support for local product launch, sales and marketing
PHARMA MARKET ACCESS SERVICES BULGARIA –PRICING REIMBURSEMENT STRATEGY
The reimbursement system in Bulgaria is lengthy and complex. While changes to both pricing and reimbursement are likely it will take time to develop a proposal that is workable within the Bulgarian regulatory system and in the context of the Bulgarian National Health Insurance Fund (NHIF).
As in other areas, the Bulgarian Drug Agency (BDA) and the Ministry of Health play a key role in the market for medicines, medical devices, food supplements and cosmetics.
The intricacies and dynamics of the Bulgarian regulatory environment serve to underpin the need for new entrants to work with a local partner to better understand pricing and the reimbursement policy in Bulgaria. Only with this can new market entrants hope to get their own price and reimbursement strategies and subsequent reimbursement application right. With experienced local consultants, Grove can assist with:
- Understanding the Bulgarian reimbursement policy
- The development of appropriate pricing strategies
- Access to key opinion leaders and healthcare decision makers
- Translation of all related documentation
- Reimbursement applications/submissions
- Pricing and reimbursement status monitoring and maintenance
- Timely follow up and communication with experts
- Administrative support at all levels
PHARMA MARKET ACCESS SERVICES BULGARIA –REGULATORY AFFAIRS SUPPORT FOR LOCAL PRODUCT LAUNCH, SALES AND MARKETING
Beyond pricing and reimbursement, locally based consultants provide expert regulatory affairs support for local product launch, sales and marketing. This includes:
- Review of advertising, promotional and educational materials to meet local regulatory requirements
- Validation and submission of relevant materials to appropriate local agencies
- Provision of local management support required/relevant local databases
- Facilitation of direct communication with local healthcare professionals
MARKET ACCESS BULGARIA – COMPLIANCE/QUALITY ASSURANCE
Experienced, well-connected local Grove consultants are ideally positioned to be able to provide regulatory affairs support to ensure client compliance in terms of relevant legislation and local regulatory procedures.
Across key product areas of pharmaceuticals/medicines, medical devices and biologics, food and dietary supplements and cosmetics, areas in which Grove local consultants provide regular input to ensure client compliance include:
- Local notifications and authorization support
- RA support to meet EU serialization and NMVS (National Medicines Verification Systems) guidelines
- Manufacturing, BDA places increasing emphasis on inspection in the area of GMP
- Regulatory affairs consulting services to meet local distribution prerequisites
- Sales and marketing, providing appropriate RA support for local product launch and the review of promotional materials and patient support materials, for example
- Advertising
- Data protection and GDPR
- Packaging and labelling, to include tracking safety labelling changes
