Our Expertise
Our Expertise
We are here to help you succeed! At Healios Labs, we have the capability to strategize, plan and execute to take your product concept into a successful approval and product launch.
We provide end-to-end development solutions through formulation and analytical development, process development, scale-up, regulatory submission and approval. With experience in designing complex generics and 505(b)2 products with expertise in topical, transdermal, ophthalmic, and injectable dosage forms.
Reverse Engineering
Reverse Engineering
Learn MoreFormulation & Process Development with Scale-Up Support
Formulation & Process Development with Scale-Up Support
Learn MoreAnalytical Development
Analytical Development
Learn MoreAnalytical Validation
Analytical Validation
Learn MoreBioequivalence Testing - In Vitro and In Vivo
Bioequivalence Testing - In Vitro and In Vivo
Learn MoreIn Vitro Test Capabilities
In Vitro Test Capabilities
Learn MoreRegulatory Strategy and Submission
Regulatory Strategy and Submission
Learn MoreRegulatory Strategy and Submission
Regulatory Strategy and Submission
Learn MoreCommercial support
Commercial support
Learn MoreCommercial support
Commercial support
Learn MoreIn Vitro Test Capabilities
In Vitro Test Capabilities
Learn More
Reverse Engineering
For most generic products, the FDA requires that both the new product and the branded product have a sameness in components and From both a qualitative (Q1) and a quantitative perspective (Q2), the generic product must be close to the approved branded product and this will be the first step in most cases.
Reverse Engineering involves development of analytical methodologies to deformulate and accurately estimate the quantities of each excipient in the Reference product. Healios Labs has a full-scale reverse engineering laboratory and the in-house expertise to develop unique methods to capably quantitate some of the toughest excipients.
Formulation & Process Development with Scale-Up Support
Formulation and process development are key processes to achieve the best drug product possible. Both processes are required to control the drug product to the needed quality attributes so that each commercial batch is saleable.
- Formulation development involves both sourcing the most appropriate grade materials tailored for product design and assessment of the drug within the formulation. The reverse engineered formulation is used to assess the drug-excipient compatibility, initial stability and develop specifications.
- Our Process Development strategy deploys a systematic Design of Experiments (DoE) approach to how the product will be made which can be translated to scale at the manufacturing site of your choice. Deploying a Quality by Design (QbD) approach for all avenues of our development program, we ensure that the Critical Quality Attributes (CQAs) are controlled to optimize batch success rate and to be ready for your regulatory dossier. With a full understanding of current cGMP standards, the process development team can support many dosage forms, drug-device combinations and packaging configurations.
- Scale-Up Support W We also have a wide network of established manufacturers of various dosage forms we can recommend and engage, should you require help with.
Analytical Development
Analytical assessment is a key component of development where the goal is to design the quality control strategies for the drug product.
- Analytical Development
At Healios Labs, our scientists can expertly craft analytical methods specific to the product in hand. Developing specific methods for your product is a key component of the development process as it will provide goal posts for the formulation and process development activities. Analytical development is the driver for setting appropriate quality control specifications for your commercialized product.
- Analytical Development
Analytical Validation
- Our analytical team can provide validation services with our cGMP certified laboratory and support your cGMP testing needs at any stage of development.
- Stability study support is available for both long-term storage and testing.
Bioequivalence Testing - In Vitro And In Vivo
As part of any generic (including 505 b(2)s) development process, regulatory agencies will want to have proof of equivalence or superiority to the existing product on the market for the same indication within the same route of administration. To make sure that your product has the best chance of regulatory acceptance, Healios Labs can help strategize, design and execute the proper in vitro and in vivo clinical studies to prove that the products we design are equivalent to the existing market authorized competitor.
In Vitro Testing in-house
- With expertise in topical, transdermal and ophthalmic drug design, we have the ability to develop, validate and execute the in vitro/in vivo testing portion of the bioequivalence standard in our cGMP grade suite.
- The advantage of doing both drug development and the in vitro/in vivo development within the same facility is that we can design the drug product with the in vitro test in mind and test it in parallel.
For our In Vitro Test Capabilities, please click here.
In Vivo Partnerships
With novel and complex drug products, there may be a need for a tailored strategic regulatory pathway which involves more complex trials . If your product has needs beyond the capabilities of our laboratory, we have many supporting partnerships that can facilitate the required studies to accomplish your goals.
Regulatory Strategy And Submission
- Regulatory strategy for your product is important to chart the fastest path to commercialization. Healios can offer strategic consultation and planning for your regulatory submission dossier to have the best chances of success.
- Writing and reviewing submission documentation can be a daunting task but our team has experience in writing comprehensive documentation that will detail the needed information for any product development aspects in accordance with ICH guidance and with the current eCTD format.
Commercial Support
Planning for an eventual launch has multiple demanding factors and with the experience of launching several products, our team can plan the launch activities such as process validation, brand labeling and batch manufacture scheduling.
