Overview
The Republic of Latvia offers good scope of business opportunities for foreign medicinal products and medical device manufacturers. The State Agency of Medicines (SAM) of Latvia oversees the regulations for medicines and medical devices in the region. To get the market access, manufacturers might face challenges navigating through the complex regulatory procedures that range from regulatory requirements, registration procedures and market authorizations.
Freyr, as a global Regulatory Solutions and Services provider, assists manufacturers to keep abreast with the market updates and navigate through the complex regulatory procedures that range from dossier compilation, regulatory submissions for obtaining market approvals in time. Freyr’s capabilities to provide registration and approval assistance in Latvia span across:
- Medical Devices
- Pharmaceuticals
- OTC
- Biologics & Biotech
- Cosmetics
Freyr Offerings
- Strategic Regulatory Consulting
- Strategic business development focusing on the European market
- Regulatory roadmap for market access
- Regulatory Affairs & Regulatory intelligence
- Registration pathways and license management services
- Market Authorizations
- End-to-end operational support
- Dossier preparation, review and management
- Regulatory Submissions
- Medical Writing
- Pharmacovigilance
- QPPV
- Risk Management
- GCP
- Market assessments
- In-country representation
Freyr Advantages
- Strategic and well-versed local regulatory knowledgebase – with State Agency of Medicine
- Expert Regulatory team with proven global RA expertise
- Proactive and Collaborative approach
- Quick turnarounds and faster time-to-market
- Keeping abreast with region-specific legislation and Regulatory guidelines