Indæa Co.

Indæa OÜ is an innovative SME with a state-of-the-art human-centric purpose-led approach in life science. 🧭 Our team is focused on global complex regulatory, R&D, quality & sustainability projects with the mission of inspiriting advances in life science toward a healthier & sustainable world. Our IMPACT alphabet: 🧬 A - Advanced Therapies/ATMPs 🪢 B - Borderline & Combined products 💅 C - Cosmetics 🩻 D - Digital(AI), In-Vitro & Medical Devices 🐝 E - ESG standarda & Sustainability 🍏 F - Food Supplements 💊 G - Generics & Biologics 💡 H - Health Innovations Our SUPPORT alphabet: ✔️O - OPERATIONS - clinical, regulatory & safety ✔️P - PROJECT LEADERSHIP - planning, setting, execution & governance in R&D, regulatory & quality, ✔️Q - QUALITY - assurance & management systems, ✔️R - REGULATORY - strategy, science (R&D), operations, compliance & affairs ✔️S - SUSTAINABLE DEVELOPMENT - strategy, certification & reporting, ✔️T - TRAINING - design & execution, ✔️U - US/CA & EU Representation, ✔️V - Vigilance - Pharmaco & Materio: systems, operations, EU QP & RP roles. Our approach ENABLERS: 💧ESSENCE - understanding the client's needs and providing adequate support ⚙️EFFICIENCY - simplified internal processes and efficient external onboarding 🧠EVOLUTION - continual growth & commitment to continual improvement 🎥 ENTIRETY - the power of "a full picture" & openness in exiting the comfort zone We consider AGILE quality systems vital for the success and joy in the execution of any project, thus we follow the ISO 20700:2017 Guideline for Management Consultancy Services. 🔗 From 🪽 idea to impact 🐢 🫴 www.indaea.co We Create. Advise. Rethink. Evolve. Join us! 🌍