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Our Expert Consulting
Our Services
PharmiOnyx offers a comprehensive suite of consulting services for pharmaceutical and biotechnology organizations.
End to end CMC strategy and execution for small molecules and biologics, from early phase development through commercial readiness, including process and analytical development, technology transfer, stability programs, and regulatory submission support.
Analytical method development design, qualification, and validation strategy, protocol and report review, and troubleshooting support for small molecules and biologics, with execution managed through your internal labs or qualified testing partners.
Bioanalytical method development and validation in biological matrices, supporting PK/PD strategy, biomarker planning, and immunogenicity assessment from nonclinical through clinical stage programs.
Clinical trial readiness support spanning CMC and IND enabling package coordination, investigator brochure CMC content, and cross-functional alignment between development, quality, and regulatory teams ahead of clinical milestones.
Regulatory strategy consulting including pathway assessment, agency meeting preparation support, briefing document development, and submission strategy guidance for IND, NDA, BLA, and MAA filings across global markets.
Digital transformation consulting to help pharmaceutical and biotechnology organizations move from paper-based and siloed data systems to structured, digital data acquisition, the foundation required before analytics, AI, or automation can deliver real value.
AI and machine learning consulting to turn digitized pharmaceutical and analytical data into real-time dashboards, stability and shelf-life predictions, automated report drafting, and trend analysis that supports faster, more confident decision-making.
Laboratory automation consulting covering automated sample preparation, robotic sample transfer between instruments, automated data acquisition, and streamlined reporting to reduce manual lab work and improve throughput and consistency.
Vendor management consulting for CDMOs, contract testing laboratories, and other outsourced partners, including vendor selection, performance oversight, quality agreements, and relationship management to keep outsourced programs on track.
Workshops, seminars, leadership coaching, and certification programs in pharmaceutical and biotechnology CMC, analytical development, and quality, drawing on direct industry experience and designed for conversational, hands-on learning rather than passive reading.
A podcast featuring conversations with pharmaceutical and biotechnology leaders, covering CMC, analytical development, regulatory strategy, and career insight, alongside motivational and educational speaking engagements for industry audiences.