MK Science & Regulation advances regenerative innovation through scientific rigor, ethical leadership, and real-world regulatory intelligence—translating complex science, compliance, and product-development realities into frameworks professionals can trust, adopt, and defend.
years across healthcare innovation
Global work across
years across healthcare innovation
FDA PURAN
...
A global authority in regulatory science for regenerative and innovative medicine
MK Science & Regulation advances regenerative innovation through scientific rigor, ethical leadership, and real-world regulatory intelligence—so progress scales with integrity and without sacrificing compliance.
What we do
We bring clarity to high-stakes decisions—where science, regulation, and execution must align.
Regulatory Strategy & Development Pathway
We guide companies through the complex regulatory landscape that governs drug, biologic, device, and advanced therapy development. Our work includes regulatory strategy design, gap analysis, IND/IDE-enabling planning, and preparation for key FDA interactions—ensuring that innovation progresses through credible, defensible regulatory pathways.
Clinical, Evidence & Development Execution
We support the design and operational alignment of preclinical and clinical development programs. From protocol strategy and regulatory submissions to trial execution and data oversight, our approach ensures that scientific evidence is generated efficiently, ethically, and in a form regulators can evaluate with confidence.
Compliance, Quality & Lifecycle Oversight
We help organizations establish durable compliance systems across the product lifecycle—from early development through market approval and post-market safety monitoring. Our expertise spans quality systems, pharmacovigilance, regulatory documentation, and audit readiness to ensure organizations meet the highest regulatory and governance standards.
Built for professional and stakeholder audiences
MK Science & Regulation works with pharmaceutical, biotechnology, medical device, and healthcare innovation organizations navigating complex regulatory environments. Our work supports executive teams, scientific leaders, compliance professionals, and clinical development groups responsible for advancing products under FDA and global regulatory frameworks.
MK engagements prioritize scientific integrity, regulatory discipline, and responsible communication—ensuring that innovation progresses with credibility and long-term defensibility.
Dr. Mukesh Kumar
PhD, MBA, RAC, DABRM
Scientific authority. Regulatory intelligence. Governance-minded leadership.
Dr. Mukesh Kumar is a serial entrepreneur, senior executive, author, and regulatory strategist with more than 18 years of experience across pharmaceutical, biotechnology, and medical device development. He is the founder of Akan Biosciences and FDAMap—two Maryland-origin organizations focused on regulatory science, clinical development strategy, and FDA compliance consulting. His work combines scientific depth, regulatory expertise, and operational discipline to guide complex healthcare innovations from concept to regulatory approval.
Dr. Mukesh Kumar
PhD, MBA, RAC, DABRM
Scientific authority. Regulatory intelligence. Governance-minded leadership.
Dr. Mukesh Kumar is a serial entrepreneur, senior executive, author, and regulatory strategist with more than 18 years of experience across pharmaceutical, biotechnology, and medical device development. He is the founder of Akan Biosciences and FDAMap—two Maryland-origin organizations focused on regulatory science, clinical development strategy, and FDA compliance consulting. His work combines scientific depth, regulatory expertise, and operational discipline to guide complex healthcare innovations from concept to regulatory approval.
Academic & Training Footprint
He has trained more than 10,000 students and professionals over two decades and teaches as an Adjunct Professor in Regulatory Sciences at George Washington University School of Medicine—building capability in the next generation of practitioners and leaders.
Writing & Public Education
His weekly blog, FDA Puran, reaches a global professional readership and translates complex regulatory realities into practical clarity.
- PhD in Biochemistry
- RAC-certified regulatory professional (RAPS, USA)
- Certified clinical trialist (Johns Hopkins Bloomberg School of Public Health)
- Diplomate, American Board of Regenerative Medicine
- Compliance inspector and certifier
Governance-minded advisory for high-stakes innovation
MK is built around governance and defensibility. Dr. Kumar advises executives and Boards to reduce ambiguity, strengthen decision quality, and keep strategy aligned with responsible boundaries—because credibility is a long-term asset, not a campaign.
Board involvement (examples):
- Vivacelle Bio, Inc. (Kansas)
- ResQ Pharma, Inc. (Illinois)
- Kibow Pharmaceuticals, Inc. (Pennsylvania)
- Amarex Biosciences, Pvt Ltd (New Delhi, India)
- Pepfactor, Inc. (Sydney, Australia)
Publications
& Media mentions
ThinkMoCo – Official Biography
Official biography highlighting leadership in regulatory affairs and healthcare innovation.
FDAmap Clinical – Leadership
Team
Leadership profile focused on regulatory strategy, clinical research, and quality systems.
EU Agenda – Speaker Profile
Speaker profile featuring expertise in regulatory science and global healthcare.
FDAmap Clinical – Articles &
Insights
Collection of articles on regulatory strategy, clinical trials, and compliance.
Akan Biosciences – Leadership
Profile
Profile highlighting experience in biotechnology and regulatory advisory.
Top Doctor Magazine – Feature
Article
Featured article on contributions to regulatory affairs and clinical development.
ProStemEX® — A globally trusted platform for regenerative solutions
Shop professional-grade solutions with clear standards, responsible framing, and consistent quality—so you can choose with confidence.
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FDAMap®
Explore FDAMap®, a regulatory intelligence and consulting platform supporting pharmaceutical, biotechnology, and medical device companies in navigating FDA pathways, clinical development strategy, and global regulatory compliance.
FDA Puran — Regulatory insight for healthcare innovators
FDA Puran® is a widely followed
regulatory science blog authored by Dr. Mukesh Kumar, translating complex FDA frameworks, policy developments, and clinical development realities into practical insights for professionals across the healthcare industry.
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MK Science & Regulation
MK Science & Regulation
Regulatory Science • Compliance • Evidence Strategy
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