Outsourcing strategy
What to outsource, at which clinical stage, and to one partner or two. The partner chosen for early clinical supply can end up making the commercial product, so the choice is tested against the commercial plan first.
Choose the right CDMO, then hold it to the plan.
For biotech and life-sciences companies outsourcing to a contract development and manufacturing organisation (CDMO), with a focus on biologics. We act for you until the partner delivers to plan. You decide; we bring the comparison, the numbers and the people to run the process.
How we work with you
From the outsourcing decision to the first batch, and after.
Use us for the whole process or for one step: an RFP for a single programme, a review of a contract you already have, or governance of a partner you already use. The same process applies to contract research organisations (CROs).
Partner search and screening
Contract manufacturers screened on technical fit, capacity and available slots, regulatory track record and location. The result is a shortlist worth auditing with your quality team.
RFP and proposal comparison
One requirements package for every bidder, so proposals compare line by line: total cost, timeline, batch assumptions and what each one leaves out.
Negotiation and contract
Price, reserved capacity, change-order rules and your right to move the process to another site, negotiated with your legal counsel. The quality agreement is settled alongside, with your quality team.
Technology transfer
Followed week by week from the first technical meeting to the first batch, with open issues, owners and dates in one place.
Partner governance
Performance measures, quarterly reviews, change orders checked before they are signed, and a clear escalation route.
· Realised result: a manufacturing partner selected at about half the incumbent's manufacturing cost for the same scope (medical devices)
Our position
On your side of the table.
Opyflow takes no commission, referral payment or preferred-supplier arrangement from the contract manufacturers we assess.
About Opyflow
Opyflow is an operations and supply chain consultancy, founded in 2019, working with manufacturers in regulated and high-complexity industries. Offices in Kiryat Ono, Israel and Melbourne, Australia; projects across Israel, Europe, the US and India. The senior person you talk to is the one who does the work.
We are done when it's in the P&L.
Describe the situation to the senior person who would do the work. You don't need to prepare data for it, and if we are not the right firm, we will say so.