About Us
Who we Are
At Healios Labs, we’re committed to bringing innovative medicines to market faster. We’re a team of experienced scientists and regulatory experts who specialize in formulation development for complex generics and branded pharmaceuticals.
What We Do:
- Innovative Formulations: We create cutting-edge formulations for a wide range of dosage forms.
- Regulatory Expertise: We navigate complex regulatory landscapes to ensure timely market entry.
- Quality Assurance: We prioritize quality and compliance to deliver exceptional products.
Why Choose Us?
- Experienced Team: Our team, led by Dr. Lakshmi Raghavan, brings decades of industry experience.
- Tailored Solutions: We offer customized solutions to meet your specific needs.
- Dedicated Partnership: We work closely with you to achieve your goals.
Let’s work together to bring your vision to life. Contact us today to learn more.
Our 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.
Our 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.
Innovation and Excellence
Client centric Approach
Quality Compliance
Collaboration
Integrity and Transparency
Mutual Respect
Our Quality & Compliance
Our secret ingredient is our Development Quality Assurance team who constantly innovates and executes robust QA procedures to ensure the world class quality!
Scope of Work
- Document Management System: Streamlined processes for efficiency.
- Standard Operating Procedure: Clear guidelines for excellence in a consistent manner.
- Customer Meeting and Training Program: Collaborative growth with engaging sessions.
- Change Control System: Responses in the fast lane to the change of needs.
- Self-Inspection: To uphold our high standards we do regular checks.
- Qualifications: Assessments for operational readiness thoroughly.
- Review and Evaluation: Examining Master Formula Card, Validations, Protocols, and Reports.
- Quality Controls: Complying with the requirement for the utmost stringent standards to be applied to all starting raw materials, intermediates and bulk products.
- Safety Policy: Safety should be your main concern to be able to work normally.
- Environment Policy: Commitment to sustainability and to responsible practices.
Good quality is not a checkbox action at Healios; it is our way of life!
Regulatory Approvals
Proven Success in FDA Approvals
We haven’t yet received approvals for our products at Healios, but our team has rich experience in managing the regulatory side and getting approvals from reputable bodies including FDA and EMA. Given this expertise, we know how best to implement regulatory strategies and overcome challenges.
Our innovative pipeline gets us excited, and we remain committed to delivering the absolute highest standards of quality and compliance, guaranteeing safety and efficacy in every formulation. We will turn your revolutionary ideas into commercially viable products and help you bring product to the market sooner. From the world class expertise of our team, you can be assured that your drug development program is in safe hands who can tackle the regulatory complexities.
OUR TEAM EXPERIENCE
Discover the Healios Broad Spectrum Experience
We leverage extensive experience to meet your formulation needs across various dosage forms and innovative technologies. Our skilled team collaborates closely with regulatory bodies globally, including the US FDA and EMA, to ensure smooth development and compliance for your projects.
Drug Name | Dosage Form | Route of Delivery | Regulatory Pathway | Drug Modality | Formulation Type | Regulatory Scope | Client Geography |
Drug 1 | Eye Drops | Ophthalmic | 505(b)(1) | Small Molecule | Solution | USFDA | USA |
Drug 2 | Long-Acting Injectable | Parenteral | 505(b)(2) | Biologic | Emulsion | EMEA | Europe |
Drug 3 | Creams | Topical | 505(b)(j) | Small Molecule | Ointment | TGA | Australia |
Drug 4 | Nasal Spray | Nasal | 505(b)(1) | Peptide | Suspension | Health Canada | Canada |
Drug 5 | Gel | Transdermal | 505(b)(2) | Small Molecule | Gel | USFDA | Worldwide |
OUR BUSINESS MODELS
The pharmaceutical development landscape is currently undergoing a dynamic transformation in today’s context, bringing forth challenges for organizations on a range of fronts which inhibit innovation and prolong market entry. Our Fee for Service and Licensing models allow Healios to craft custom solutions to meet our partners’ particular project needs. What we’ll do for you depends on your needs – if you need targeted support for niche formulation issues or are looking for a partner to help take your formulation from concept to commercialization, our approaches should help you to get what you need.
Fee-for-Service
Need a little help? We’re your flexible sidekick!
Licensing
Get the wealth of experience out there and let the creativity fly!
Meet our team
Our team is dedicated to the advancement of pharmaceutical formulation. We are developing a wide range of the dosage forms under the guidance of Dr. Raghavan, including topicals, ophthalmics, transdermal patches, otic and nasal formulations, oral liquids and intricate injectables. We take a constructive, problem solving approach, utilizing our scientific expertise alongside innovation as we meet challenges. We see each project as an opportunity to explore and innovate and are dedicated to stretching today’s practice to provide effective and reliable solutions. We are open to collaborating with you to turn your ideas into operational realities and to prove that creativity and originality can be a component of scientific inquiry.
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. Dr. Raghavan has complete end to end product development understanding covering new and generic drug products. As a guru in the world of topicals and transdermal products, he works to provide guidance to advance pharmaceutical innovation in semisolid dosage forms as well as to deliver superior patient care.
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 from biospecimen sourcing, drug discovery and medicinal chemistry through to process chemistry, formulation development, preclinical & clinical, pharmacovigilance, regulatory, business development and market access. Furthermore, he has excellent market research and analysis skills, strategic planning, relationship building, competitive analysis skills, marketing, corporate finance, investment banking, and export import management.
Ms. Radhika Raghavan
Chief Financial Officer / 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.
Radhika is recognized for her strategic expertise in financial planning, budgeting, and analysis, as well as her ability to align HR initiatives with business objectives. Her deep understanding of organizational dynamics has made her a trusted leader in areas such as talent acquisition, onboarding, and the execution of comprehensive HR strategies.
Throughout her career, Radhika has built and led high-performing teams, developed scalable HR infrastructures, and implemented sound financial systems that support long-term success. At Healios Labs, she continues to play a pivotal role in shaping the company’s financial health and organizational culture.
