Overview
Israeli Regulatory environment is one of the most dynamic yet complex to navigate through to obtain product authorizations. With the Ministry of Health, Israel, overlooking all the regulatory activities in a stringent manner, companies intend to enter the region might face starting hiccups navigating through the unknown Regulatory procedures such as registration processes and obtaining marketing authorizations for new or existing Medical Devices and Medicinal Products.
Assisting companies to minimize the compliance related risks while entering the Israeli Life Sciences market, Freyr as a preferred global Regulatory partner provides Regulatory Affairs consultancy to register and get market approvals for Medical Devices and Pharmaceuticals. To expedite the processes, Freyr is capable to provide Regulatory consultancy in the areas of:
- Drugs
- Medical Devices
- Biotech
- OTC
Freyr Offerings
- Strategic Regulatory Consulting
- Regulatory Affairs
• New product registration
• Post-approval support (renewals, variations, line extensions, etc.)
• Labeling and Packaging material localization & translation
Freyr Advantages
- Strategic and well-versed local regulatory knowledgebase – with Ministry of Health, Israel
- 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