Drug Development Consulting
At Ambrosia Ventures, we understand the complexities and challenges of transforming scientific discoveries into market-ready therapies. Our Drug Development Consulting services provide comprehensive, strategic guidance to navigate the intricate landscape of drug development, ensuring efficient pathways from discovery to commercialization.
Pre-Clinical & Clinical Development Planning
Our approach to pre-clinical and clinical development planning optimizes your path to market while maintaining rigorous scientific standards. We create comprehensive development strategies that integrate CMC (Chemistry, Manufacturing, and Controls) planning with your broader objectives.
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Through strategic clinical trial design and management, we ensure every milestone aligns with your development goals. Our resource optimization and timeline management strategies maximize efficiency without compromising quality.
Regulatory Compliance & SubmissIon Support
We excel at navigating complex regulatory requirements with strategic thinking. Our expertise covers IND (Investigational New Drug) and NDA (New Drug Application) preparations, ensuring your submissions meet all regulatory standards.
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Our regulatory compliance support includes FDA (Food and Drug Administration) meeting preparation and global requirement alignment. We provide comprehensive documentation planning and submission management services that keep your development program on track.
Quality Assurance & Compliance for Drug Development
Quality excellence drives our approach to drug development. We implement GMP (Good Manufacturing Practice), GCP (Good Clinical Practice), and GLP (Good Laboratory Practice) compliance strategies tailored to your needs.
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Our quality assurance services include SOP (Standard Operating Procedure) development and CAPA (Corrective Action and Preventive Action) system optimization. We ensure your processes maintain compliance while supporting operational excellence.
Clinical Trial Design & Management
Success in clinical development requires expert planning and execution. Our clinical trial design services optimize protocols while ensuring efficient patient recruitment and site selection strategies.
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We provide comprehensive clinical operations support, including EDC (Electronic Data Capture) management and CRO (Contract Research Organization) oversight. Our approach guarantees smooth trial execution and optimal resource utilization.
Risk Assessment & Mitigation in Drug Development
Effective risk assessment and mitigation protect your development program. We identify potential challenges early and implement robust monitoring systems to track progress and performance.
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Our risk management approach includes emergency response planning and supply chain optimization. We ensure your program stays on track while maintaining compliance and quality standards.
Our Approach
We implement a systematic methodology that includes strategic assessment, custom strategy development, and continuous optimization. Our quality-focused approach ensures excellence at every stage of drug development.