Working with its clients to ensure a successful outcome in terms of market access, Grove local consultants provide expert advice in three key areas:
- Pricing and reimbursement
- Regulatory affairs (RA) support for local product launch, sales and marketing
- Pharma compliance
- Pharma quality assurance
PHARMA MARKET ACCESS LATVIA – PRICING AND REIMBURSEMENT STRATEGY
While membership of the EU has meant a move to regulatory harmonization, the Latvian healthcare sector remains underfunded and pricing and reimbursement systems are complex.
Recognizing the challenges of encouraging manufacturers to invest in a small market such as the Latvian market, regulators are keen to reform the current regulatory system. Although inevitably it will take some time, it is hoped that dialogue between manufacturers and the regulators will ultimately result in a more streamlined, investor-friendly regulatory system.
The Latvian State Agency of Medicines (SAM) plays the key role in the market for medicines, medical devices, food supplements and cosmetics.
The still complex regulatory procedures in the Latvian market require careful navigation. Only with an understanding of local reimbursement policies, can new market entrants hope to get their own reimbursement strategies and subsequent reimbursement submissions right. With experienced local consultants based, Grove can assist with:
- Understanding the local pharmaceutical reimbursement policy
- Understanding pricing regulations
- The development of appropriate pricing strategies for the Latvian market
- Access to key opinion leaders and healthcare decision makers
- Translation of all related documentation
- Support with reimbursement applications
- Reimbursement status monitoring and maintenance
- Timely follow up and communication with experts
- Administrative support at all levels
MARKET ACCESS LATVIA – 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 SERVICES LATVIA – PHARMA COMPLIANCE AND PHARMA QUALITY ASSURANCE
Experienced, well-connected Grove consultants, based in the country, are ideally positioned to be able to provide regulatory affairs support to ensure client compliance in terms of relevant local legislation and regulatory submissions requirements.
Across key product areas of pharmaceuticals/medicines, medical devices and biologics, food and dietary supplements and cosmetics, areas in which Grove 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, within which QA and good pharmaceutical manufacturing practice requirements must be met
- RA 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 regulations and guidelines
- Data protection and GDPR
- Packaging and labelling, to include tracking safety labelling changes
Grove provides market access consultancy services across the following product areas:
- Pharmaceuticals/medicines/drugs/medicinal products
- Medical devices
- Biologics
- Cosmetics
- Food and dietary supplements
