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CMC Support
Product Characterization
Product Characterization
At neXpharm, we specialize in providing expert guidance throughout the CMC processes in pharmaceutical and biotechnology sectors. Our team of experienced consultants ensures that your drug development is streamlined and compliant with all regulatory requirements. We aim to empower your team with knowledge and resources necessary for successful product development.
Product Characterization
Product Characterization
Product Characterization
At neXpharm, we specialize in unlocking the full story of your molecule. Our team of analytical experts partners with you to design and execute customized characterization strategies that meet regulatory expectations and accelerate development timelines. Whether you're working with peptides, oligonucleotides, fusion proteins, or complex biologics, we bring deep modality-specific knowledge and cutting-edge analytical tools to the table.
Our consultants can lead characterization efforts directly in your lab or seamlessly manage contract testing labs to deliver high-resolution insights—from structural identity and purity to potency, stability, and comparability. With neXpharm, you gain clarity, confidence, and control over your product’s analytical profile—ensuring it’s ready for every milestone from IND to BLA.
Manufacturing
Product Characterization
Regulatory Documents Support
At neXpharm, we empower pharmaceutical and biotech companies to scale with confidence. Our manufacturing support services are built to optimize process development, streamline tech transfers, and ensure GMP compliance from early-phase to commercial launch. Whether selecting the right CDMO, navigating global regulatory expectations, or resolving scale-up challenges, we bring deep expertise and hands-on leadership to every step.
With a focus on precision, speed, and operational excellence, neXpharm helps you transform manufacturing complexity into competitive advantage—delivering therapies that are ready for the market and built to last.
Regulatory Documents Support
Regulatory Documents Support
At PharmiOnyx, we provide expert support for regulatory document authoring and strategy across all phases of development—from IND and IMPD to NDA, BLA, and MAA. Our team ensures alignment with global health authority expectations, including FDA, EMA, TGA, ANVISA, and beyond.
We translate complex analytical and CMC data into submission-ready content that withstands scrutiny, accelerates review timelines, and drives approvals.
Custom Training Development
Empowering Teams. Elevating Standards. Driving Results.
At PharmiOnyx, we deliver tailored training programs designed to meet the unique needs of your department and accelerate team performance. Whether you're scaling technical capabilities or building leadership bench strength, our curricula are built for impact.
📘 Training Areas Include:
CMC & Analytical Development: Method development, validation, regulatory documentation, and tech transfer
Pharmaceutical Manufacturing: Process optimization, scale-up strategies, equipment qualification, and batch record revie
Pharmaceutical Development: Formulation strategies, stability programs, and lifecycle management
GMP & Compliance: Audit readiness, data integrity, and global regulatory standards
Leadership & Team Building: Project management, cross-functional collaboration, and coaching for high performance
Led by seasoned industry experts, our training combines scientific depth with real-world application—empowering your teams to lead with confidence and deliver with precision.
Analytical Development
Precision. Speed. Confidence. Powered by PharmiOnyx.
At PharmiOnyx, we redefine analytical development by combining scientific rigor with agile execution—delivering data you can trust, faster. Whether you're advancing a first-in-class biologic or scaling a late-phase program, our services are built to accelerate your path from molecule to market
Welcome!
Looking to accelerate drug development with precision, speed, and scientific rigor? Let’s build the future of pharma together.