Indæa OÜ is an innovative SME with a state-of-the-art human-centric purpose-led approach in life science, headquartered in Tallinn, Estonia.
🧭 Our team is focused on global complex regulatory, including R&D, quality & sustainability projects with the mission of inspiriting advances in life science toward a healthier & sustainable world.
Our main IMPACT areas:
🧬 (Bio)pharmaceutical
🩻 Medical, In Vitro & Digital Devices &
🐝Sustainability.
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 - affairs, compliance, operations, science (R&D) & strategy
✔️S - SUSTAINABLE DEVELOPMENT - strategy & certification,
✔️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 critical for the success and joy in the execution of any project, thus we are established & act in line with the ISO 20700:2017 Guidelines for Management Consultancy Services.
We
Create.
Advise.
Rethink.
Evolve. Join us! 🌍
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Industry
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Business Consulting and Services
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Company size
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2-10 employees
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Type
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Privately Held
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Founded
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2024
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Specialties
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Regulatory Affairs, Clinical Regulatory, Regulatory Operations, Regulatory Compliance, Regulatory Intelligence, Regulatory Science, R&D, Regulatory Strategy, Quality Assurance, Quality Systems, Auditing, QMS, Sustainable Development, SDGs, and ESG standards