
Iris Attorneys specializes in regulatory affairs consultancy for the pharmaceutical, food, cosmetics, and broader life sciences sectors. We act as a crucial partner for businesses navigating complex laws, agreements, and guidelines to ensure efficient operations and market access.
It takes (30) working days to obtain a premise license to operate a manufacturing or sale of pharmaceutical, cosmetic, or food products.
Marketing Authorization (MA) for a pharmaceutical product can be issued within ninety (90) days for pharmaceutical Products under WHO collaborative procedure, Orphan pharmaceutical products, Pharmaceutical products approved by WLA countries, and Products from EAC partner states. However, through reliance and Mutual recognition, in only thirty (30) days, the MA can be obtained.
Business registration in Rwanda takes only six (6) hours. RDB website (reference)
Clinical trial certificates are issued within (60) working days.
Import and Export permits are issued within three (3) working days.
Life Sciences and Pharmaceuticals, Food and Cosmetics Sector, Intellectual Property, and related sectors.
Compliance with regulatory requirements, Compliance with WTO-TBT requirements
Mergers & acquisitions involving pharmaceutical and food companies or services (manufacturing, wholesalers, or retailers)
Advisory on Pension, occupational hazards, and medical scheme matters (e.g. sickness, employment injury, unemployment, invalidity, old age, death and health care)
Product liability claims and fraud investigations (warranties, warnings, labeling, product literature, product recalls
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