Working with its clients to ensure a successful outcome in terms of market access, Grove consultants based in Serbia 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 SERVICES IN SERBIA – PRICING AND REIMBURSEMENT STRATEGY
Pricing and reimbursement policies remain extremely complex, less than transparent and a source of constant frustration for healthcare companies. As an accepted candidate for accession to the EU, the Serbian healthcare industry has been pushing hard for regulatory and best practice changes.
A positive shift in the mindset of the regulatory authorities is now evident and it is hoped that the introduction of initiatives such as the National Strategy on Medicines and managed entry agreements will help to drive the healthcare market forward as will the inevitable harmonization of regulation in line with EU requirements in the run up to the country becoming a full member of the EU.
As in other areas, the Medicines and Medical Devices Agency (ALIMS) and the Ministry of Health play a key role in the market for pharmaceuticals, medical devices, food supplements and cosmetics.
The highly bureaucratic, complex and still unpredictable local regulatory environment requires very careful navigation. Only with an understanding of the Serbian reimbursement policy, can new market entrants hope to get their own reimbursement strategies and subsequent reimbursement submissions right. With experienced local consultants, Grove can assist with:
- Understanding the Serbian pharmaceutical reimbursement system and policy
- Understanding local pricing regulations
- The development of appropriate pricing strategies
- Access to key opinion leaders and healthcare decision makers
- Translation of all related documentation
- Reimbursement applications
- Reimbursement status monitoring and maintenance
- Timely follow up and communication with experts
- Administrative support at all levels
MARKET ACCESS SERBIA – REGULATORY AFFAIRS SUPPORT FOR LOCAL PRODUCT LAUNCH, SALES AND MARKETING
Beyond pricing and reimbursement, local Grove 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 – PHARMA COMPLIANCE AND PHARMA QUALITY ASSURANCE
Experienced, well-connected locally based Grove consultants are ideally positioned to be able to provide regulatory affairs support to ensure client compliance in terms of relevant legislation and regulatory procedures in the Serbian market.
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, for example reporting supplies and sales of medicinal products to national authorities
- Manufacturing, within which QA and good pharmaceutical manufacturing practice requirements must be met
- Clinical trials, within which QA and the requirements for good clinical practice in clinical trials 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, both non-prescription to the general public and advertising to the professional healthcare community
- Data protection
- 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
