SGI Consulting

Strategic Nonclinical and Regulatory Guidance for Global Drug Development

Specialized scientific, toxicology, and regulatory guidance for sponsors preparing programs for U.S., Asia, and European markets

SGI Consulting supports sponsors through the technical decisions that define nonclinical drug evaluation and regulatory submission strategy. Our experience spans diverse therapeutic areas, including oncology, neurology, infectious disease, cardiovascular, metabolic, inflammatory, immune, ophthalmic, dermatologic, orthopedic, and medical device programs.

Through a consortium of specialized scientific, regulatory, clinical, CMC, and toxicology experts, SGI Consulting aligns the right expertise around each program. This model allows us to support a wide range of modalities, from biologics and small molecules to vaccines, oligonucleotides, gene therapies, antibodies, ADCs, cellular therapies, medical devices, and highly purified botanicals, while illuminating your path forward with clarity, efficiency, and confidence.

SGI Consulting Service Offerings

SGI Consulting provides nonclinical development consulting, translational toxicology support, and regulatory strategy services for sponsors preparing biopharmaceuticals, small molecules, and complex therapeutic products for clinical development. From early development planning through IND-enabling strategy, SGI helps sponsors design nonclinical programs, interpret toxicology findings, prepare for regulatory agency interactions, and develop submission-ready documentation.

Through a coordinated consortium of scientific, toxicology, CMC, clinical, and regulatory subject matter experts, SGI helps sponsors align study planning, safety assessment strategy, regulatory expectations, and development-stage decision-making. Our approach is designed to support preclinical development, IND readiness, FDA communication, and regulatory submission planning with practical guidance from experienced drug development professionals.

Nonclinical Program Design for Biopharmaceuticals and Small Molecules

Strategic nonclinical program design for biopharmaceuticals and small molecules, including preclinical study planning, safety assessment strategy, toxicology considerations, and regulatory alignment to support IND-enabling development, clinical readiness, and regulatory submission planning.

Translational Toxicology Support and Interpretation

Expert translational toxicology support to help sponsors interpret nonclinical toxicology findings, assess human relevance, clarify safety signals, and support clinical development, regulatory strategy, and risk-based decision-making.

Regulatory Training

Customized regulatory training for drug development teams to help sponsors understand agency expectations, FDA submission requirements, regulatory strategy, and development-stage decision-making.

Regulatory Agency Communications

Strategic regulatory agency communication support, including FDA meeting preparation, briefing materials, agency feedback interpretation, and next-step planning for development, IND readiness, and submission strategy.

Regulatory Submissions

Strategic regulatory submission support, including document planning, scientific content review, agency-ready documentation, and response support across key drug development and submission milestones.

Referral Services and Communication Coordination for API Manufacturing

Referral and communication coordination support for API manufacturing and CMC-related development needs, including expert connections, technical discussion alignment, CMC coordination, and development-stage communication support.

Need support beyond what’s listed here? Connect with us to discuss your program needs and identify the right scientific, regulatory, or development expertise.