Pharmaceutecal & Development
We specialize in optimizing and refining pharmaceutical processes from early-stage research to scalable, robust procedures. Our team ensures efficient, reproducible, and compliant process development to support successful technology transfer
Full service from Procurement to release
Seamless development requires careful coordination at every stage. Our expertise ensures a streamlined journey from sourcing high-quality materials to regulatory approval, providing full support for your project’s success
Analytical Services
Ensuring quality, safety, and compliance demands strong analytical expertise. Our services provide accurate, reliable data throughout drug development.
- Method Development: We create precise, compliant analytical methods.
- Method Validation: We confirm accuracy, specificity, and regulatory adherence.
- Stability Services: We evaluate product integrity for shelf-life and approvals.
Customized Services
Tailored solutions for complex drug development. We provide specialized expertise for projects requiring unique handling, regulatory compliance, and strategic development.
- Hazardous Molecules: Safe, precise handling of high-potency compounds, ensuring compliance and formulation accuracy.
- Orphan Drugs: Expert support for rare disease therapies, covering formulation, analytics, and regulatory pathways.
505b2
The 505(b)(2) NDA pathway accelerates drug approval by leveraging existing data, reducing development time and costs.
At Viorainnovation, we guide you through the process with:
- Regulatory Strategy: Tailored plans optimizing existing data for approval.
- Clinical Study Support: Design and management to meet FDA requirements.
- Regulatory Submission: Expert preparation for a smooth approval process.
Maximize efficiency with our expertise. Contact us to navigate the 505(b)(2) pathway successfully