Getting your medical device approved shouldn’t take years of trial and error

I help early-stage MedTech founders get a clear EU MDR, UKCA and/or FDA regulatory strategy in just 30 days so they can move forward with confidence, reduce delays and get to market faster

The problem:
Many founders are unsure which pathway applies, what documents are required or how to avoid months of regulatory back-and-forth. Without a clear plan, they risk burning runway, missing opportunities and losing investor confidence

How I help:

- Map the exact regulatory pathway (CE, UKCA, 510(k), De Novo, PMA)
- Define intended use & classification to align with regulators
- Build a step-by-step submission readiness plan
- Provide hands-on support for technical documentation, QMS & audits
- Guide devices including SaMD, AI/ML, hardware and IVDs through IEC 62304, IEC 82304, applicable ISO standards and emerging AI frameworks

Full capabilities:

Regulatory consulting: CE marking under MDR/IVDR, UKCA certification, FDA pathways (510(k), De Novo, PMA). PRRC & UKRP services. Gap assessments, submission support & strategic planning

Quality assurance: Implement & remediate QMS to ISO 13485 & MDSAP. Lead audits, manage CAPAs & complaints, support risk management (ISO 14971), process validation (IQ, OQ, PQ) & sterilisation (ISO 11607). Certified ISO 13485 Lead Auditor (CQI/IRCA)

Digital health / SaMD: Compliance with IEC 62304, IEC 82304 & AI/ML frameworks. Software validation & CSV for regulatory alignment

eQMS platforms: Implement Greenlight Guru, Qualio, MasterControl, JIRA & Confluence, with CSV to ensure audit readiness

Due diligence: Regulatory & QMS assessments for investors, accelerators & M&A. Identify red flags in technical documentation & submissions before they become costly

Training & microconsulting: For teams & founders building internal capability. CQI/IRCA-registered tutor for MDR, IVDR, ISO 13485, ISO 14971 & MDSAP

I’m a startup advisor and competition judge for MedTech Innovator, Springboard Enterprises and MassChallenge. As a trainer and host of The MedTech Podcast, I work with founders, investors and accelerators worldwide to deliver regulatory clarity and practical strategies

I combine regulatory expertise with a practical, execution-focused mindset. Clients value my ability to cut through complexity, reduce time to market, pass audits and scale confidently, whether launching a first product or expanding internationally

If you’re navigating regulatory uncertainty or preparing for growth, let’s connect

🎙️ The MedTech Podcast | 📺 YouTube: @KarandeepBadwal

Karandeep Badwal

Indæa OÜ

💡I am the founder & CEO @ Indæa OÜ, a consulting e-company with a state-of-the-art human-centric purpose-led approach to life science. 
It is headquartered in Tallinn, Estonia with the main operating office in Banja Luka, Bosnia & Herzegovina.  

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, organizational, regulatory & safety
> P - PROJECT GOVERNANCE - planning, setting, execution & oversight
> Q - QUALITY - auditing, assurance & systems
> R - REGULATORY - affairs, compliance, intelligence, science (R&D) & strategy
> S - SUSTAINABLE DEVELOPMENT - auditing, certification, reporting & strategy
> T - TRAINING - creation & execution 
> U - US Agent & EU Representation
> V - Vigilance - PV & Materio: auditing, operations & vigilance experts allocation

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! 🌍

Founder • CEO

Irigai Consulting I Founder of Indæa OÜ

💡I founded Irigai Consulting (previously Regularis) to outsource global regulatory, R&D & quality management projects, with a mission of inspiriting advances in life science toward a healthier world.

Achievements, I am the most proud of, 
📌 > 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 executed, 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, performed directly or via third parties in the last 5 years, 
📌 Almost ALL types of EU/EMA & FDA regulatory procedures experience, including orphan, pediatric, and expedited development program applications & 
📌 Quality management systems designed from scratch - performing the role of Process Owner &
📌 Strong quality assurance 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 & system development, and project & quality management in (bio)pharmaceutical, medical, in-vitro & digital devices industries.

Principal Consultant

Phortas

🧭 My role is to guide the Phortas' clients in developing the best-suited regulatory strategies and development programs for their products encouraging them to start interactions with the authorities at the early development stage.

Achievements, I am the most proud of, 
📌 In Regulatory Strategy: Acceptance of CP eligibility request by EMA for the first-in-class medicinal product in the EU,
📌 In Quality Assurance: ✔️Creation of Regulatory Consulting QMS proposal and participation in creation of regulatory SOPs &
✔️ High-level of quality assurance awareness brought to the regulatory team
📌 In Project Leadership: Regulatory & team allocation advisory to the Sponsor's Interim Head of Department, in > 6 months transitional period &
📌 In Thought-Leadership: Poster Presentation at RAPS EuroConvergence 2024 on expedited drug development programs, challenges & opportunities, by EMA & FDA.

Phortas provides world-class product development support. It is uniquely positioned to provide access to the best expertise and ensure you meet all requirements while developing your products. 
We support your development programs through the core competencies that define our success: 
☑️ World-class expertise - our experts are established professionals in their field and truly dedicated to assigned projects
​☑️ Fast acting - we can define the project scope and provide our support immediately​ &
☑️ Flexibility - we support our clients in ad-hoc, short-term, or long-term projects, using a staggered approach to address all client needs.

Sr. Regulatory Affairs Manager

Arriello

🧭 My role is to provide regulatory expertise and guide to Arriello's customers in reaching their regulatory strategy goals in a Faster, Better & Smarter way.

Achievements, I am the most proud of,
📌 In Regulatory Strategy: ✔️Successful global registration & life-cycle strategies for 2 Biosimilar products in 1 year period,
✔️ Sinchronised MA transfer & product supply strategies for MRP product encompassing > 20 EU/EEA countries in 1 year period, as well as 
✔️ Complex regulatory procedure (e.g. manufacturing site transfer) execution & governance, from A to Z,
↳ from setting strategy, to authority decision, 
↳ with comprehensive generic portfolio & 
↳ simultaneous ongoing procedures in different stages, for Mid Pharma in 1 year period
📌 In Quality Assurance: ✔️Regulatory processes audits, inspections, and self-ispections, participation & findings improvement ✔️Processes owner, creation, implemention & governance of relevant SOPs ✔️High-level of quality assurance awareness brought to the regulatory team
📌 In Project Leadership: Project Setting Lead in project with Big Pharma, led > 25 internal & external project team members, project governance & support in design of adequate KPIs, in 1 year period
📌 In Thought Leadership: Participated in RAPS EuroConvergence 2020 & 2021 as Moderator of Biosimilar session and Presenter of e-PI & PRO/PROMs presentations

Arriello is a leading life sciences consultancy, offering expert guidance in regulatory affairs, pharmacovigilance, and quality compliance. 
Its global services span the product lifecycle from clinical to post-submission regulatory affairs, pharmacovigilance, and quality & compliance. 
Headquartered in Ireland and with operations across Europe, we provide services and solutions globally. 
☑️ With decades of experience, 
☑️ ISO:9001 certification, and 
☑️ a friendly, diverse team, we‘ve been a trusted partner to the life sciences industry, primarily with pharmaceutical and biotech companies since 2008.

Galenika a.d.

🧭 My role is to provide regulatory expertise and interpret local requirements, guiding the sales & marketing teams in reaching full regulatory compliance & commercial success, ensuring uninterrapted therapies availability to the patients in need.

Achievements, I am the most proud of,
📌 In Regulatory Strategy: Timely life-cycle strategies execution & governance considering the comprehesive company portfolio, encompassing > 110 generic & specialty products, > 40 dental materials & > 15 food suplements
📌 In Quality Assurance: Set & maintenained MA holder regulatory compliance, with proactive audit or inspection readiness
📌 In Project Leadership: ✔️ Adequate life-cycle maintenance strategies enabling > 30% budget reduction
✔️ Smooth role induction & general regulatory training of junior staff stepping into regulatory

For almost 80 years, Galenika has been in the service of health with medicines that in most cases mean life. In October 2017, Galenika became part of the international company EMS, the largest and most prestigious company in the Latin American market, known and recognized in the world.
☑️ The vision of the company is very simple, we want to take care of the health of our users with top quality products. 
☑️ Under the slogan "The brand you trust", we are trying to raise consumer awareness of the importance of health. We are not satisfied with what is expected of us, we always try to do more than that. 
☑️ The greatest strength of our company is our employees. The combination of experience and youth aims to make Galenika a leader in the country, a respectable player in the region, and a conqueror of new markets.
Galenika continues its old tradition, with a clear vision - to always be in the right place - at the TOP.

Regulatory Compliance & Regulatory Affairs Responsible Person

Interpromet d.o.o.

🧭 My role is to provide regulatory, market access & vigilance guidance contributing to the company's regulatory compliance & success.

Achievements, I am the most proud of,
📌 In Regulatory Strategy: ✔️ Established feasible regulatory strategies & submission plans, interpreting local legislation aligned with current EU regulations (MDD/AIMDD/IVDD)
✔️ Reached submission timelines & goals in complete Medtronic Inc portfolio - CRDM and VASCULAR 
↳ from strategy, technical files gap analyses, and creation submission dossiers in line with adequate conformity procedure performed,
↳ through submission and interactions with the authority until approval,
↳ to life-cycle and product change assessment, and further adequate notifications or variations &
✔️ Ensured Local Authorised Representative (AR) Regulatory Compliance.
📌 In Project Leadership: ✔️ Success in the role of the Main Company Point of Contact in front of the Client
✔️ Simplified Cross-functional & Cross-cultural project coordination & governance, including budget estimation, and design of project monitoring tools & repository architecture & 
✔️ Streamlined project induction & brief general regulatory training to junior staff steping into regulatory.

Interpromet Novi Grad Ltd. is one of the three leading pharmaceutical wholesales in Bosnia and Herzegovina. The company is singled out 
☑️ by a wide range of products, 
☑️ a swift and reliable delivery, an all-inclusive service, and 
☑️ the top-quality relations which we have developed with renowned world producers and buyers throughout Bosnia and Herzegovina.

Regulatory Affairs, Local PV & Tender Associate

PharmaChoice Canada

Pharmacy Intern as a foreign trained Pharmacist

STADA Group

Medical Representative

Parmacy Lek

Licensed Pharmacist

Medical High School Banja Luka - Pharmacy

Pharmaceutical Technology Professor (lab practice)

Hello, and thank you for visiting my profile!

💡I am the founder & CEO of Indæa OÜ, a consulting e-company with a state-of-the-art human-centric purpose-led approach in life science, headquartered in Tallinn, Estonia with the main operating office in Banja Luka, Bosnia & Herzegovina. 

Our team is focused on providing support in 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 GOVERNANCE - planning, setting, execution & oversight
✔️Q - QUALITY - auditing, assurance & systems
✔️R - REGULATORY - affairs, compliance, intelligence, science (R&D) & strategy
✔️S - SUSTAINABLE DEVELOPMENT - auditing, certification, & strategy
✔️T - TRAINING - creation & execution 
✔️U - US Agent & EU Representation
✔️V - Vigilance - auditing, operations & vigilance experts allocation

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.

🙌 Thank you for learning a bit about me & my company, let’s connect, as I also want to learn a bit about you.

👀 If you want to learn more how we @Indæa OÜ evolve & can evolve together,

👣 Follow us @Indæa OÜ & reach out at www.indaea.co 🫶

We 
Create. 
Advise. 
Rethink. 
Evolve. Join us! 🌍

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