From Concept to Commercialization.
MAKK Incorporation provides end-to-end consulting services for businesses developing and introducing healthcare, medical device, and AI-based solutions. Our expertise spans business strategy, regulatory and legal compliance, and intellectual property protection to ensure smooth market entry and sustainable growth.
From Concept to Commercialization.
MAKK Incorporation is a specialized consultancy firm offering strategic business and legal advisory services to companies and AI technologies in Healthcare, IVF & MedTech space. We support businesses across their innovation journey — from product ideation and validation to launch, commercialization, and global scale-up — while ensuring complete regulatory, legal, and IP compliance.
MAKK Incorporation blends deep business strategy with strong legal, regulatory, and IP expertise to help innovators successfully navigate complex pathways to market. Our multidisciplinary team works across the full product lifecycle, guiding clients through:
Business Consulting & Commercialization
We design actionable strategies for:
– Product launch & market entry
– Distribution and channel partnerships
– Pricing and reimbursement planning
– Commercial due diligence
– Business development & investor alignment
SaaS & AI Commercial Readiness
We assist technology and AI-based SaaS companies in the healthcare space with:
– Product market readiness assessment
– Product evaluation and technical review
– Pilot studies and trial support
– Commercial launch strategies
– Client acquisition frameworks
Sales & Marketing Enablement
We help build strong market presence through:
– Marketing strategy & execution
– Digital and offline brand positioning
– Sales team recruitment & training
– Distribution network development
– Go-to-market sales architecture
Regulatory & Compliance Advisory
Comprehensive regulatory support including:
– Product registration and approvals
– Regulatory submissions (FDA, CE, CDSCO)
– Documentation, certifications & audits
– Medical device, healthcare, and AI-specific compliance
– Ongoing regulatory maintenance & risk monitoring
Legal Consulting & Market Entry
We provide legal and operational guidance for:
– Licensing & distribution agreements
– Cross-border partnerships
– Local market compliance
– Corporate structuring for new geographies
– Litigation support
Intellectual Property & Trademark Strategy
Protecting innovation is at the core of our advisory. We assist with:
– IP landscaping & strategy
– FTO & Patent advisories
– Patent drafting, filing and prosecution
– Trademark, design & copyright registration
– IP portfolio management
– Enforcement, oppositions & dispute support
AI Risk, Governance & Ethics Advisory
We help organizations build responsible, scalable, and compliant AI systems by offering support in:
– AI validation & algorithm transparency
– Data governance and privacy compliance
– Ethical AI frameworks
– Risk identification & mitigation strategies
From Concept to Commercialization.
We develop tailored strategies for product launches, market entry, distribution partnerships, pricing models, and reimbursement mapping. Our team helps align clinical validation, commercial strategy, and investor expectations for a successful go-to-market plan.
Regulatory & Compliance Advisory
Comprehensive support for product registration, regulatory submissions (FDA, CE, CDSCO), and ongoing compliance with healthcare standards. We ensure that your innovations meet the necessary medical device and AI-specific regulatory frameworks.
Legal Consulting & Market Entry
We develop tailored strategies for product launches, market entry, distribution partnerships, pricing models, and reimbursement mapping. Our team helps align clinical validation, commercial strategy, and investor expectations for a successful go-to-market plan.
Intellectual Property & Trademark Strategy
Protecting innovation is central to our mission. MAKK assists with IP audits, patent filing strategies, trademark registration, and IP enforcement. We ensure that your proprietary technologies and brands are safeguarded across markets.
AI Solutions Risk & Ethics Advisory
We help organizations design responsible AI strategies aligned with ethical and regulatory standards. Our team advises on AI validation, algorithm transparency, data governance, and risk mitigation.
Our integrated approach ensures healthcare and AI innovators can move from concept to market with clarity, compliance, and confidence.
Evaluate the innovation, market landscape, and regulatory requirements.
Build a tailored commercial, regulatory, and IP roadmap.
Implement compliance, licensing, commercialization, and market entry activities.
Support scale-up, post-market surveillance, and long-term sustainability.
Leadership Team
Our leadership comprises senior experts with over 20 years of experience in business strategy, regulatory affairs, intellectual property, and legal advisory.
Successful Market Entries
Our team has successfully guided over 100 market entries, helping clients launch healthcare, medtech, and AI solutions globally.
Global Clients
MAKK Incorporation serves clients across the world, building lasting partnerships to ensure market success and compliance.
Ready to bring your healthcare or AI solution to market? Connect with our team for a personalized consultation.
info@makk.in
+91 9891166997
India | Europe | USA
