About Us Equimed Alliance is dedicated to accelerating the availability of innovative, high-quality medicines for U.S. patients by bridging global pharmaceutical innovation with U.S. regulatory and commercial pathways. We partner with international biopharma companies to navigate complex approval processes, optimize market entry strategies, and ensure that breakthrough formulations reach the U.S. market efficiently and affordably. Our purpose is to expand access, advance innovation, and improve patient outcomes through trusted global collaboration.
Market feasibility, competitive landscape, and opportunity assessment
FDA pathway identification and approval strategy
Commercial readiness and go-to-market planning
InsightX derived pathway Development and scale-up strategy aligned with US regulatory expectations
Integrated regulatory, CMC, and commercialization planning
Decision support across critical development and launch milestones
NDA, ANDA, 505(b)(2), and DMF regulatory pathways
Submission planning, regulatory writing, and filing support
FDA interaction management, including responses to agency queries
IP landscape assessment and freedom-to-operate analysis
Exclusivity and lifecycle management strategies
Alignment of regulatory and IP approaches to strengthen long-term protection
Advisory support from experienced pharmaceutical scientists and leaders
Troubleshooting complex formulation, development, and scale-up challenges
Practical insights grounded in real-world regulatory and commercialization experience
Expertise I possess extensive expertise in pharmaceutical sciences, encompassing drug discovery, development, and formulation optimization. I am skilled in analytical techniques such as HPLC, GC, and spectroscopy, and have a strong understanding of pharmacokinetics, pharmacodynamics, and dosage form design for tablets, capsules, and injectables. My experience spans preclinical and clinical trial design, pharmacovigilance, and regulatory compliance with FDA, EMA, and ICH guidelines. I am proficient in Good Manufacturing Practices (GMP), quality control, quality assurance, process validation, and scale-up manufacturing, including sterile and aseptic processing.
Insights I have strong pharmaceutical insight, allowing me to understand drug development, formulation, and regulatory processes deeply. I can analyze complex scientific and clinical data to make informed decisions. My insight helps anticipate challenges in manufacturing, quality control, and compliance, ensuring efficient and safe pharmaceutical operations. I combine technical knowledge with strategic thinking to optimize drug development and delivery.
Partners
