Irigai Consulting I Founder of Indæa OÜ

🧭 Irigai Consulting (previously Regularis) has been founded to outsource global regulatory & quality management projects, with a mission of inspiriting advances in life science toward a healthier world. 🎈Achievements, we are the most proud of, are ✔️> 20 clients, including big pharma & EU-based consultancies, ✔️> 25 project team members, internal & external, led as project setting lead, ✔️> 30 processes, created, documented, implemented & governed, ✔️> 55 projects, from early non-clinical through registration to life-cycle or post-market stage, above & beyond, ✔️ > 100 global markets interactions, encompassing ALL EU/EEA, CH, EMA, FDA & UK jurisdictions, ✔️ > 150 global regulatory & clinical regulatory submissions, directly or via third parties in the last 5 years, & ✔️ Almost ALL types of EU/EMA & FDA regulatory procedures, including orphan, pediatric, and expedited development program applications ✔️ Quality management systems designed from scratch - performing the role of Process Owner & ✔️ Strong quality assurance awareness embedded in the project execution, as well as performing the role of CAPA owner with a commitment to continual improvement. We @ Irigai Consulting are all “e”, as we are ☑️ experts in our areas in different life science industries, ☑️ experienced, with > 40 years of combined experience (only our owners) & ☑️ evolving continually - being committed to continual growth, envisioning proactively challenges & enabling their improvements. ⚙️ We can support you in regulatory strategy & affairs, product development, and project & quality management in (bio)pharmaceutical, medical, in-vitro & digital technology industries. 👀 If you want to learn more about how we evolve & can evolve together, 👣 Follow us @ Indaea OÜ Linkedin page and visit our website at www.indaea.co We Create. Advise. Rethink. Evolve. Join us! 🌍

Website

www.indaea.co

External link for Irigai Consulting I Founder of Indæa OÜ

Industry

Business Consulting and Services

Company size

2-10 employees

Headquarters

Banja Luka

Type

Self-Employed

Founded

2019