Your oligonucleotide CMC department, on demand
We support you along all phases of drug development, from defining the right strategy to submitting your regulatory applications.
Your strategy is our mission, your success is our priority.
Our Services
CMC Strategy and Development
External Manufacturing and Supply
Regulatory and Authority Interactions
Your CDMO is your infrastructure. That relationship is your program.
RFPs and CDMO selection for oligonucleotide API, raw materials, and drug product. MSA and Quality Agreement negotiation. Day-to-day program leadership so someone with technical authority is on every call. Plus cost-of-goods modelling with the decisions that can affect that number.
Module 3 is written once and read for the next decade.
IND and IMPD Module 3 authoring. Briefing books, scientific advice and pre-IND meetings, and defending the package in the room. I've written and deffended these in both sides as sponsor and CDMO.
You have a molecule and a critical timeline. What you don't have is a CMC organisation.
Process and analytical development strategy, phase-appropriate specifications, comparability, stability programs, scale-up and tech transfer, through to process validation. I set the plan, then run it with your team and your external partners.
Not sure which you need?
Start with a Phase Readiness Assessment
A fixed-scope, two week review of where your CMC package actually stands against your next milestone, and what is missing.
Contact Us
Your questions are our mission.
Get in contact!
info@oligo-consulting.com