Formulation Innovation and Development
At Nuvex Biotech, we transform your active pharmaceutical ingredient (API) into a safe, effective, and market-ready drug product. Our team of formulation scientists and engineers leverages cutting-edge technologies and a science-driven approach to develop innovative formulations tailored to your specific needs. Whether working on complex drug delivery systems, orphan drugs, or personalized medicines, we provide end-to-end support to accelerate the product journey from concept to clinic.
Quality by Design (QbD)
We implement QbD principles to design robust and regulatory-compliant formulations:
Define critical
quality attributes (CQAs):
Identify Critical Material Attributes (CMAs) & Critical Process Parameters (CPPs) to Ensure batch-to-batch consistency.
Design of
Experiments (DoE):
Optimize formulation parameters and physicochemical attributes.
Risk
assessment:
Mitigate potential risks early in the development process.
Topicals, Transdermals, and Complex Formulations
We develop high-performance advanced formulations for challenging drug delivery needs:
Topicals:
Creams, gels, and ointments for skin conditions.
Transdermals:
Patches and gels for systemic drug delivery.
Complex
formulations:
Lipid-based systems, nano-encapsulation, and micellar solutions.
Orphan Drugs
We offer tailored formulation strategies for specialized therapies:
Low-volume
production:
Develop cost-effective solutions for small batches.
Patient-centric
designs:
Focus on ease of use and patient compliance.
Regulatory
support:
Navigate orphan drug designation and approval processes.
Personalized Medicines
Create tailored therapies to meet individual patient needs:
Dose-specific
formulations:
Customize dosages for precision medicine.
Patient-specific
delivery systems:
Develop formulations for targeted delivery.
Flexible
manufacturing:
Produce small batches for niche markets.
Why Choose Our Formulation
Development Services?
Regulatory-driven
formulation expertise:
Ensuring GMP-compliant, scalable, and stable formulations.
Comprehensive formulation
lifecycle support:
From R&D to market launch.
Expertise Across
Therapeutic Areas:
Expertise in rare diseases and chronic conditions with long-term stability and efficacy for sustained-release formulations.
High-throughput
screening:
Rapid evaluation of multiple formulations and processes.
Advanced
analytics:
State-of-the-art instrumentation for precise characterization and testing.
Our Formulation
Development Process
Initial
Consultation:
Understand your project goals, timeline, and budget.
Pre-formulation
Studies:
Conduct physicochemical characterization and excipient compatibility analysis.
Formulation
Design:
Develop and optimize the drug formulation using QbD principles.
Process
Development:
Scale up and validate the manufacturing process.
Analytical
Testing:
Ensure quality and stability through rigorous testing.
Regulatory
Support:
Prepare documentation for regulatory submissions.