Concept development Consulting
- Concept Development Consulting
- Deformulation/Reverse Engineering
- Formulation Research Development
- Analytical Research Development
- In-vitro Bioequivalence
- In-vitro Studies (IVPT/IVRT)
- Scale-up and Technology Transfer
- CMC, Dossier Compilation & Regulatory Support
- Clinical Research Support
- Clinical Supplies & Commercial Manufacturing Support
Product Development Consulting with Strategic Rational Design
We believe that a thoughtful and holistic approach is crucial for the successful product development in the realm of formulation science at Healios Labs. Our concept development consulting services are aimed at taking innovative ideas and delivering them as effective, and market ready, solutions to both semisolids and sterile dosage forms.
Rational Design: A Multi-Faceted Framework
Our consulting process is centered on a rational design framework that unifies scientific rigor, technical feasibility, regulatory compliance and economic viability. With this structured methodology, we can wade through the complexities of formulation development — We tie up all loose ends and provide comprehensive solutions.
Development of Quality Target Product Profile
Our engagements begin with collaborative work with our clients to develop Quality Target Product Profile (QTPP) for the client’s pharmaceutical product. They play an essential part as indispensable blueprints that map your product’s formulation strategy against regulatory norms and customer expectations so that the development process follows a success path.
Targeted Formulation Strategies
We specialize in developing drug products specifically formulated for different diseases and dosage forms. By identifying the singular characteristics and criteria of each of your targeted demographics, we optimize therapeutic efficacy and increase patient compliance to guarantee that your quality product reaches your desired levels of safety and efficiency.
Comprehensive Feasibility and Risk Management
It is important to understand the landscape in formulation development. We do extensive feasibility assessments, including technical, manufacturing and scale-up, regulatory, and economic factors, to identify potentially significant risks and opportunities in the early stages of the process. We run rigorous risk assessments and scenario analyses so you’re ready to overcome challenges and make your project more resilient.
Quality by Design: Ensuring Excellence from the Start
We embed Quality by Design (QbD) principles into our development processes in line with ICH Q8 guidelines. By being proactive in specifying critical quality attributes (CQAs) and context of use (COU) early in the project, it drastically reduces the risk of expensive later stage changes.
Strategic Intellectual Property Consulting
We know that you need to protect your innovations. Our intellectual property strategy incorporates our full range of consulting services to develop first to file patent applications on formulated products, identifying potential patent infringing competitor formulations and alternative protection mechanisms including proprietary excipient specifications and confidential processes. This strategic plan guarantees your product still have competitive edge in the market.
Technology Evaluation and Reverse Engineering
To stay ahead in the field of formulation science one needs to understand the emerging technologies. For your project, we conduct thorough technology evaluations and scout for innovative formulation strategies that your project can leverage. Our reverse engineering services also give you insights into products currently in the market that you can compare and develop strategies accordingly.
Expert Support for Due Diligence & Litigation
Our Chemistry, Manufacturing, and Controls (CMC) assessments and expert statements within due diligence processes provide valuable insights to stakeholders so they can make informed decisions and trust your product’s development pathway. We also provide litigate support for patent challenges and recommend a guided path to overcoming litigation challenges.
