About Us

  • About Us
  • Why Stark Pharma?

Global Reach. Local Expertise. Purpose Driven Innovation

Incorporated in 2014, Stark Pharma began with a clear vision: to provide world-class Pharmaceutical, Medical Device, Healthcare IT, and Consulting solutions and services that improve lives across the globe. As our capabilities and partnerships expanded, we established Stark Pharma in USA, Canada and India — solidifying our position as a global enterprise with strong regional expertise.

We operate at the intersection of Science, Technology, and Healthcare—serving pharmaceutical, biotechnology, medical device, software as medical device (SaMD), consumer health, and cosmetics sectors. Our team of seasoned professionals delivers integrated solutions spanning regulatory affairs, clinical development, manufacturing support, compliance, software, and strategic staffing.

Global Presence

  • USA – Strategic consulting, Healthcare IT, and client services hub.
  • India – Headquarters for research, operations, and manufacturing partnerships.
  • Canada – Technology and regulatory center serving North America and EU clients.

More Than a Service Provider — A Strategic Partner for Growth

At Stark Pharma, we go beyond project delivery. We build long-term relationships rooted in trust, quality, and performance. Here’s why global life sciences companies choose us:

  • Proven Track Record – Over a decade of success serving Fortune 500 pharmaceutical companies, FDA/EMA-approved CROs, top generic manufacturers, and medical device innovators.
  • End-to-End Solutions – From early-stage R&D and regulatory strategy to staffing, software, and commercialization—our 360° service model simplifies complex challenges.
  • Regulatory Expertise – Our global team of regulatory professionals navigates diverse compliance frameworks including US FDA, EMA, CDSCO (India), and Health Canada.
  • Integrated Global Operations – With operations in India, Canada, and the USA, we blend cost-efficiency with responsiveness and cultural alignment for each market we serve.
  • Tech-Enabled Approach – We invest in digital tools and AI-driven platforms that enhance compliance, speed, and decision-making across the product lifecycle.
  • Flexible and Scalable – Whether you’re a startup seeking a partner or a global leader expanding markets, we tailor our solutions to your size, scope, and speed.

Partner with Stark Pharma — where science meets service, and innovation meets impact.

Clinical Research

Regulatory Affairs

Contract Manufacturing

Software Solutions

Strategic Resourcing

Medical Device Design & Development

CRO Services

IT Services

Our Vision

At Stark Pharma, our vision is to be the most trusted global partner in advancing healthcare innovation from molecule to market. We aspire to lead the life sciences industry by delivering integrated solutions that bridge the gap between scientific discovery and patient access. By leveraging our global presence in the USA, Canada, and India, we aim to provide unparalleled expertise in pharmaceuticals, medical devices, healthcare IT, and consulting services. Our commitment is to foster long-term partnerships rooted in trust, quality, and performance, ensuring that every solution we offer contributes to improved patient outcomes and global health advancements.

Our Mission

Our mission is to advance global health by providing reliable, innovative, and cost-effective solutions to life sciences companies. We are dedicated to delivering excellence through a combination of scientific expertise, regulatory compliance, and digital transformation. Our services encompass the entire product lifecycle, from early-stage research and development to regulatory strategy, manufacturing support, and commercialization. By integrating cutting-edge technology and a deep understanding of global regulatory frameworks, we strive to simplify complex challenges for our clients. Our goal is to empower healthcare organizations to bring safe, effective, and accessible products to market, ultimately enhancing the quality of life for patients worldwide.

Our Testimonials

"Stark Pharma's expertise in regulatory affairs was instrumental in our successful NDA submission. Their team's deep understanding of FDA requirements and meticulous attention to detail ensured a smooth approval process. Their support has been invaluable to our operations"

Director of Regulatory Affairs, Mid-Size Pharma Company, USA

"Navigating the EU MDR compliance landscape was daunting, but Stark Pharma's guidance made it manageable. Their comprehensive understanding of regulatory nuances and proactive approach helped us achieve certification ahead of schedule. Their partnership has been a cornerstone of our compliance strategy"

Head of Quality Assurance, Medical Device Manufacturer, Germany

"Integrating Stark's IT solutions, particularly their Stark ERP platform, streamlined our processes significantly. Their team's responsiveness and technical acumen have been critical in enhancing our platform's reliability and security"

CTO, HealthTech Startup, India

"Stark Pharma's biostatistics team provided insightful analyses that were pivotal in our clinical trial phases (2018-2024). Their ability to interpret complex data and present actionable insights accelerated our decision-making process. Their collaboration has been a key asset to our research endeavors"

Chief Scientific Officer, Biotech Firm, Canada

"Stark Pharma's strategic resourcing services have been exceptional. They provided us with highly qualified professionals who seamlessly integrated into our Validation, Regulatory and Clinical projects, enhancing productivity and innovation. Their global reach and understanding of regional requirements have been particularly beneficial"

Operations Manager, Pharmaceutical Company, USA