Partner with us, build your success
We are your dedicated partner, helping you in navigating technical challenges, optimizing the regulatory pathways and developing products that meets the highest standards. Our team led by Dr. Lakshmi Raghavan has 25+ years of experience with a diverse range of sterile and non-sterile dosage forms, including topical, transdermal, ophthalmic, Otic and injectable products and can offer high quality custom solutions to fit the needs of small, medium and large companies. Leverage our cutting-edge methodologies in reverse engineering, Formulation & Analytical development, scale up. Bioequivalence and In vitro Testing (IVRT & IVPT).
At Healios Labs we strive to improve access to affordable and effective medications for patients, drive success through collaboration, and turn your pharma vision into market success.
PRODUCTS WE DEVELOP
Topicals
Transdermals
Inserts
Ophthalmics
Complex injectables
Otics
Nasals
Oral Liquids
HEALIOS By The Numbers
Service Offerings
Explore Our Service Portfolio for Standalone or Comprehensive End-to-End Solution
We understand the complexities of pharmaceutical industry that requires deep thinking, lots of planning and perfect execution. Our scientists are meticulous in their approach to solving problems. We navigate complex regulatory requirements, streamline our development processes that ensures product quality. Our solutions are customized to your needs and challenges in your whole life cycle development.
Concept Development Consulting
Use our strategic consulting service to turn your brilliant ideas into action plans. We help you define your vision, find market opportunities, and build a roadmap for successful development — collaborating with you along the way.
Deformulation/Reverse Engineering
Is deformulation a problem you face in the product development? With our deformulation expertise, you can benefit from product analysis to help improve your development process and be competitive in the market.
Formulation Research Development
Are you searching for a formulation development partner that starts and finishes with QbD? We have a strong history of robust formulation development tailored to your particular therapeutic need. We design our experiments for optimal delivery and patient compliance.
Analytical Research Development
We provide extensive analytical support to assure the quality, safety and efficacy of your products. We perform analytical method development, validation, and transfer.
In-vitro Studies
(IVPT/IVRT)
Utilize our world class expertise and testing resources in development, validation and conducting in-vitro release and permeation testing to assess the bioavailability of your formulations and conduct bioequivalence studies for regulatory submissions.
In-vitro
Bioequivalence
In vitro bioequivalence trials are explored involving the use of advanced analytical techniques to quantitatively evaluate the pharmacokinetic profiles of drug formulations. These studies are crucial for showing therapeutic equivalence, compliance for regulatory purposes and for supporting the development of generic pharmaceuticals that are not only similarly effective, but also similarly safe.
Scale-up and Technology Transfer
Working closely with process development team technology transfer and scale up is required to guarantee a seamless transition to registration and commercial batch sizes. Transfer from development to manufacturing is made easier by our development team, through our scalable processes and high product quality.
CMC, Dossier Compilation & Regulatory Support
For all your regulatory path development and submission, we can be your external regulatory partner. We can have our experts assemble complete regulatory documentation for your ANDA and your novel drug filings.
Clinical Supplies & Commercial Manufacturing Support
The complexities of performing clinical trials for effective product development are reduced through the operational and strategic support of our clinical research partner.
Clinical Research
Support
Our clinical research team offers strategic guidance and operational support, helping you navigate the complexities of clinical trials for successful product development.
Empowering Your Vision, Advancing Healthcare
Healios Labs is your dedicated partner in drug development. We specialize in developing complex generics and branded pharmaceuticals, bringing them to market.
Our Expertise:
- Navigating Complexity: We handle the technical challenges and regulatory hurdles.
- Custom Solutions: Tailored approaches for small, medium, and large companies.
- Cutting-Edge Science: Leverage our expertise in reverse engineering, formulation & process development, bioequivalence, and in vitro testing.
Why Choose Healios Labs?
- Dedicated Team: Led by industry experts.
- Proven Track Record: Years of experience and successful projects.
- Collaborative Approach: Working closely with you to achieve your goals.
Ready to Bring Your Vision to Life? Contact us today to learn more about how we can help.
Niche Dosage Form Expertise
Advanced Formulation Technologies
Diverse Drug Modalities
Specialty Development Programs
Novel Drug Delivery Design
Multiple Routes of Delivery
Why Partner with Healios?
We specialize in formulation development as a Contract Research Organization (CRO). Here’s why we’re the right choice for your project:
1
Deep Industry Experience
Having formulated many products in the past, we make valuable contributions and input into your project as well as increasing the probability of success.
2
Fast-Track Your Success
It means that you get to the market fast with the product without sacrificing quality in our processes.
3
Unwavering Quality and Compliance
Our practices involve the best quality assurance and adherence to regulatory set standards hence ensuring your project is safe in our hands.
4
Rationale Design based Product Development
Our Rationale Design Approach for specialty dosage forms tackles their specific challenges. We enhance the effectiveness and stability of our formulations by carefully considering scientific, technical, and regulatory factors. This way, we ensure that our drug development solutions are both effective and compliant.
5
Comprehensive Support Every Step of the Way
From initial concept to final product, our dedicated team offers extensive support, ensuring you have everything you need to succeed.
6
Expertise in Regulatory and Clinical Affairs
We know the industry complexities inside and out with strong regulatory and clinical expertise to help you overcome challenges and achieve your goals.
7
Proactive and Responsive Communication
We prefer to be proactive and responsive with our communication so as to keep you informed and involved in the formulation development process.
8
Our Strategic Presence in the USA
Make use of our strategic presence in the USA so that you can leverage our local expertise in the sphere of pharma.
9
Strong Relationship Within FDA Community
Take advantage of our relationships within the FDA community to help ensure a smoother FDA agency communication for your product development needs.
US Generic company
Working with Healios Labs has revolutionized our understanding of ophthalmic drug development. They have made significant contributions to project efficiency by developing innovative strategies for the optimization of ocular formulations and for improving drug solubility. Our formulations underwent rigorous in-vitro permeation testing (IVPT) and, further, stability assessments to ensure high levels of effectiveness and compliance. Working alongside their committed team has boosted our research through the roof.
European Generic company
Dr. Raghavan, known as the topical guru in the industry, has been the key for development of semisolid dosage forms for Healios Labs.. He did a great job at IVPT and IVRT testing, and helped us with our formulation accordingly in a way that would optimize the performance of our products and meet regulatory requirements. To me, the commitment that the Healios team has shown to scientific excellence has really helped us stand out in the market
Australian Innovator company.
We have been able to rely on Healios Labs and the game changer for our formulation project!”. With their deep expertise in regulatory pathways and new drugs, we have streamlined our development process, getting cutting edge therapies to market faster. What really differentiates this team is their commitment to quality and to designing patient centric solutions. “We are very pleased with our partnership
Resources & Insights
Your go-to source for the latest insights, updates, and expert knowledge in formulation research, development, and drug delivery—plus all the exciting happenings at Healios Labs!
Blogs
Dive into our Blogs for expert insights and discussions on the latest trends and innovations in formulation research and drug delivery.
Whitepapers
Access our Whitepapers for comprehensive analyses and research findings on critical topics in formulation and drug delivery systems.
News
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Events
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