About Us
Healios at a Glance
Healios Labs is a research-oriented pharmaceutical CDMO with proven expertise across diverse dosage forms and complex drug modalities, including HPAPIs, oncology drugs, steroidal drugs, controlled substances, and sterile formulations. Our business strategy focuses on delivering high-value, niche development programs and partnering with global pharmaceutical companies to accelerate product commercialization.
The company’s strategic approach targets technically challenging and high-barrier product domains such as topicals, transdermals, ophthalmics, injectables, otics, nasal sprays, inhalations, implants, inserts, and oral liquids, where advanced formulation and drug delivery technologies are critical. We selectively identify products and proactively execute development programs, consistently exceeding cGMP and GLP regulatory expectations.
Our capabilities span reverse engineering, formulation development, analytical research, scale-up and tech transfer, in-vitro bioequivalence, CMO/CRO scouting and alliance management, regulatory affairs, and commercialization support. These integrated services enable our clients to deliver safe, effective, and high-quality therapies to patients worldwide.
Founded and led by experienced pharmaceutical and business professionals, Healios Labs is managed by a team of highly skilled scientists and development experts renowned for their domain knowledge, attention to detail, and commitment to delivering programs successfully from concept to commercialization
OUR VISON MISSION
Mission:
Our mission is to empower pharmaceutical companies by providing cutting-edge end to end product development solutions that enhance patient outcomes. We are committed to developing safe, reliable, and progressive dosages that address unmet medical needs.
Vision
Our vision is to be the premier partner for pharmaceutical companies, delivering innovative formulation development solutions that accelerate drug development and improve patient outcomes. By combining scientific expertise with a deep understanding of industry needs, we are driving the future of pharmaceutical formulation.
Philosophy
By selectively partnering with clients globally and focusing on niche products, scientific rigor, and uncompromising quality, Healios Labs delivers differentiated, reliable, and efficient pharmaceutical development solutions that drive client success and long-term value creation.
Innovation and Excellence
Client centric Approach
Quality Compliance
Collaboration
Integrity and Transparency
Mutual Respect
Meet our team
Dr. Lakshmi Raghavan
Founder, CEO, R&D Head
Dr. Lakshmi Raghavan is an experienced Pharmaceutical Research Scientist with more than 25 years experience in research and development, and regulatory affairs. He has launched multiple successful companies, showing competence of combining sound scientific knowledge with strategic initiatives for business.
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Brijesh Gajera
Director- Business Development
Brijesh Gajera is a trained pharmacist with 15 years of experience in pharmaceutical research and worked at renowned global contract research organizations (CROs) in the U.S. and India. His work has spanned the US, UK, Europe and APAC region, advising clients on integrated drug development right…
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Ms. Radhika Raghavan
CFO / HR Head
Ms. Radhika Raghavan serves as the Chief Financial Officer at Healios Labs LLC, bringing over 25 years of leadership experience in both Human Resources and Finance. A seasoned executive and serial entrepreneur, she has consistently driven growth and operational excellence across a range of industries.
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OUR BUSINESS MODEL
The pharmaceutical development landscape is rapidly evolving, creating challenges that can slow innovation and delay market entry. Healios addresses these needs through flexible engagement models, including fee-for-service, co-development, turnkey development for out-licensing, and seamless technology transfer. Whether partners require targeted formulation support, shared-risk product development, end-to-end asset creation, or a smooth transition to commercial manufacturing, Healios delivers tailored solutions aligned with each project’s strategic objectives.
Fee-for-service
Licensing
Co-development
Tech-transfer
Quality System
Healios Labs – Quality Policy & Systems
At Healios Labs, quality is central to our commitment to pharmaceutical formulation development across a wide range of dosage forms. We deliver scientifically rigorous, reliable, and compliant development and analytical solutions through proactive planning, systematic execution, and continuous improvement.
Quality is embedded into every process through risk-based, data-driven decision-making aligned with industry best practices. Healios Labs is a USFDA-registered facility with an assigned FEI number, and all operations are conducted in accordance with cGMP and GLP norms, ensuring data integrity, traceability, reproducibility, and regulatory readiness throughout the product development lifecycle.
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- Robust quality systems governing formulation development and analytical operations
- Structured Quality Management System supporting development-stage programs
- Clearly defined quality roles, responsibilities, and accountability
- Controlled and version-managed SOPs and documentation systems
- Comprehensive laboratory records, protocols, and technical development reports
- Protocol-driven execution of formulation and analytical activities
- Secure document control, review, and archival practices
- Risk-based quality management across project lifecycles
- Routine internal reviews and data integrity checks
- Continuous monitoring of quality performance indicators
- Proactive CAPA systems for issue identification and prevention
- Cross-functional integration of quality into scientific and operational decisions
- Ongoing training to maintain technical competency and regulatory awareness
- Continuous improvement through feedback, metrics, and innovation
Our quality framework supports client development goals, regulatory submissions, and long-term partnerships built on trust, compliance, and scientific excellence.
