What we Do
Preclinical Strategy Consulting from Concept to First in Human Trial
DRUG PRODUCT
FORMULATION
LNP & Delivery System Selection, process design and optimization. Drug Product Characterization: Analytical strategy for particle size, polydispersity index (PDI), encapsulation efficiency, free vs. bound RNA, and in vitro release dynamics.
API STRATEGY
CMC Services
We bridge the gap between breakthrough RNA biology and robust, regulatory-compliant drug products. From initial sequence selection through IND/CTA filing, our CMC (Chemistry, Manufacturing, and Controls) services ensure your synthetic oligonucleotide or mRNA candidate is scalable, stable, and ready for human clinical trials.
CRO SERVICES
In Vivo Studies
We deliver end-to-end *in vivo* study design and management for precision medicine programs. Our experts optimize non-clinical workflows to rigorously evaluate bio-distribution, target potency, and safety profiles. From preliminary tissue-tropism assays to GLP-compliant toxicology, we provide actionable data that de-risks development and accelerates your targeted therapeutic to the clinic.
CRO SERVICES
First in Human IND
End-to-end regulatory and strategic oversight to transition your lead candidate from preclinical development into First-in-Human trials. From Module 3 compilation and regulatory agency briefing documents to clinical trial protocol design and safety monitoring, we streamline submission workflows, de-risk regulatory reviews, and ensure seamless clinical translation.
Syed Reza MD-PhD
Managing Partner
Syed Reza brings twenty years experience in biopharma specializing in nanomedicine technology. Syed currently leads the External Innovation and Alliance activities at NOF Corporation for the Drug Delivery Solutions business unit. Recently, Syed has consulted for various CDMOs on commercial strategy in manufacturing of complex biologics, including for Octoplus B.V, a Dutch nanomedicines company.