R&D Services
At Nuvex Biotech, we recognize that Research and Development (R&D) is the foundation of successful drug development. Our full suite of pharmaceutical R&D services is designed to support your product from the earliest stages of drug discovery to formulation innovation and beyond. From prototype evaluation to process validation, we help pharmaceutical, nutraceutical, and cosmetic companies develop cutting-edge products focusing on quality, efficiency, and compliance.
Pre-formulation Studies
Pre-formulation studies lay the groundwork for successful formulation development, ensuring that drug candidates are optimized for bioavailability, stability, and manufacturing. Our pre-formulation services include:
API
characterization:
Thoroughly analyze the active pharmaceutical ingredient (API).
Excipient
selection:
Identify excipients that enhance stability and bioavailability.
Formulation
strategy:
Develop a roadmap for formulation development based on pre-formulation data.
Solubility
Profiling:
Ensuring optimal drug absorption and delivery.
Prototype Evaluation and Testing
Our full suite of pharmaceutical R&D services includes rigorous testing to evaluate the drug prototype for feasibility, performance, and stability. It includes:
Formulation
feasibility:
Identify potential challenges early.
Preliminary Formulation
assessments:
Identifying promising formulations.
Drug
performance:
Ensure that drug meets target profiles for efficacy, stability, bioavailability, and therapeutic goals.
Scalability
for manufacturing:
Ensure feasibility for future manufacturing.
Physicochemical Characterization
Understanding the physicochemical properties of your drug substance is essential for developing a stable and effective formulation. Our advanced physicochemical characterization techniques analyze the structural, thermal, and chemical properties of APIs and excipients. Our services include:
Spectroscopic and
chromatographic analysis:
Ensuring compound purity and stability.
Particle size
analysis:
Optimize particle size for better bioavailability.
Polymorphism
studies:
Identify and characterize different crystalline forms of the drug.
Thermal and
mechanical properties:
Evaluate stability under various conditions.
Excipient Compatibility Analysis
Excipients play a crucial role in the stability and performance of your drug product. We conduct excipient compatibility studies to:
Process Development and Validation
Developing a robust and scalable manufacturing process is key to successful drug development. Our process development services include:
Process parameter
optimization:
Fine-tune manufacturing parameters for efficiency and consistency.
Scale-up
feasibility studies:
Transition from lab-scale to pilot-scale and commercial-scale production.
Process validation
(IQ, OQ, PQ):
Ensure the manufacturing process is reproducible and compliant with regulatory standards (e.g., FDA, EMA, ICH).
Why Choose Our
R&D Services?
Nuvex Biotech is dedicated to scientific excellence, regulatory compliance, and innovation. Our team of experienced scientists and formulation experts utilizes state-of-the-art technology and a data-driven approach to develop safe, effective, scalable products. With a strong foundation in Quality by Design (QbD) and adherence to global regulatory standards (ICH, FDA, EMA, TGA, DRAP), we ensure that every formulation meets the highest quality, stability, and performance standards—partner with us for reliable, compliant, and market-ready solutions backed by expertise and precision.
Our R&D
Process
Initial
Consultation:
Understand your project goals, timeline, and budget.
Feasibility
Assessment:
Conduct prototype evaluation and preformulation studies.
Formulation
Development:
Develop and optimize the drug formulation.
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.