SERVICES
Facing the complexities of drug development? Healios Labs is here to help! At whatever stage you choose to engage with us, we offer flexible, tailored services which can comprise of standalone solutions or a full end to end package. We help streamline your path to market with analytical support, formulation research, regulatory guidance, and clinical supplies for getting your innovative ideas to market efficiently and effectively. Let’s bring this project up a notch!
1
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.
2
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.
3
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.
4
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.
5
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.
6
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.
7
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.
8
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.
9
Clinical Research Support
The complexities of performing clinical trials for effective product development are reduced through the operational and strategic support of our clinical research partner.
10
Clinical Supplies & Commercial Manufacturing Support
In order to provide end to end support for clinical supplies and manufacturing services, we engage with well established partners to manufacture and supply clinical materials with timely and compliant delivery.
