If you’re an independent CMC consultant evaluating whether Callan Pharma Services is a resource worth having in your network, this post is written for you. It covers what Callan does, how we work alongside consultants in practice, and why the relationship is designed to strengthen your engagement with a client rather than complicate it.
Kevin Sill, PhD
President & Co-Founder
Callan Pharma Services
Complement, Not Competition
The most important thing to understand about Callan is the boundary of our scope. We do one thing: pre-GMP injectable and ophthalmic formulation development for small molecules and peptides. That scope is narrow by design.
Everything outside that boundary, regulatory strategy, IND authoring, CMC documentation, CDMO selection, quality systems, clinical operations, and the full range of strategic CMC work that defines a consultant’s value to a client, is not Callan’s domain. We have no capability for it and no interest in it. When a CMC consultant brings Callan into a client program, their role as the client’s primary CMC relationship is not affected. It is reinforced.
To be specific about what falls outside our scope: biologics, gene therapy, oral and solid dose formulations, GMP manufacturing, regulatory submissions, and any work that requires a validated or qualified analytical method. Callan is a research-stage lab. The outputs we produce are designed to inform development decisions and support a consultant’s CMC strategy, not to substitute for it.
What We Do
Within our scope, Callan covers the formulation science work that most early-stage programs need before a CDMO is engaged:
- Analytical method implementation and development. We either implement a client’s existing HPLC assay or develop a research-grade method suitable for formulation comparison and compound tracking. These are not validated methods; they are research tools that form the analytical foundation for the feasibility and stability work that follows.
- Formulation screening. We design and execute a screening panel against a defined Target Formulation Profile, evaluating candidate formulations for key physicochemical attributes including appearance, pH, osmolarity, concentration, and initial stability indicators.
- Pilot stress testing. We run focused stress evaluations to assess the impact of oxidation and pH range on the compound, providing directional data on degradation behavior to inform formulation decisions.
- Pilot stability assessment. Lead formulations are placed on accelerated and refrigerated stability to generate directional data. These are research-stage studies, not ICH stability programs, and are not suitable for regulatory submission.
- IP landscape review (optional). Both Callan founders are registered USPTO patent agents. For clients who want it, we can assess the formulation IP landscape, including white space analysis and identification of potentially defensible formulation approaches. For clients who have already completed their own IP work, this component is scoped out entirely. This service is always structured to feed into the work of outside patent counsel, never around it.
How the Relationship Works in Practice
The clearest way to illustrate how Callan and a CMC consultant work together is through a real engagement.
A client in the ophthalmic space, working with their CMC consultant, encountered a filter clogging problem during manufacturing. The issue was threatening their timeline and the existing team needed an independent specialist perspective to identify the root cause. Callan was engaged to evaluate the process.
We identified the source of the clogging and modified the formulation process to resolve it, without changing the formulation composition. The fix was process-level, not compositional, which meant the client’s existing formulation work remained intact and no reformulation was required.
Throughout that engagement, the CMC consultant remained the client’s primary CMC relationship. Callan provided the specialist technical work. The consultant provided the strategic context, the regulatory continuity, and the relationship with the client that a focused lab engagement like Callan’s cannot and should not replace. Neither party stepped into the other’s lane.
That is the model. Callan is most useful when a client program has a specific formulation problem, a solubility challenge, a stability question, a process issue heading into a CDMO handoff, that requires specialist bench work to resolve. The consultant identifies the need, Callan executes the technical scope, and the consultant remains in place to integrate the findings into the broader CMC strategy.
Engagement Structure
Callan proposals are structured as task-based statements of work. Each task has a defined scope, defined deliverables, and an associated cost. A client’s obligation to complete any task is independent of the others; if a program changes direction after formulation screening, there is no requirement to proceed with stability studies. This structure gives clients flexibility to adapt as their programs evolve, and gives consultants a clear framework to help their clients evaluate the proposal.
The core feasibility work typically completes in four to eight weeks. Pilot stability data requires an additional eight to twelve weeks on a fixed schedule that cannot be compressed. Written deliverables are produced at the conclusion of each task and are structured to be actionable for the client’s internal team, their development partners, and the consultant integrating the findings into a broader CMC package.
How We Communicate During a Project
Callan’s update calls are held directly with the scientists doing the bench work, not relayed through a project manager. When a consultant or client asks a technical question, the answer comes from the person who ran the experiment.
Our standard cadence is a call every other week during active lab work, with a written summary of progress and data accompanying each call. That cadence is a starting point, not a requirement. Some consultants prefer to be on every call; others prefer to receive the written summaries and engage directly with the client separately. We adapt to whatever communication structure works best for the consultant and their client. The goal is that neither the consultant nor the client is ever in a position of not knowing what is happening in the lab.
The IP Boundary
For consultants who work alongside patent counsel, it is worth being explicit about how Callan’s patent agent capabilities are scoped. Our IP landscape review is a formulation-specific technical assessment: white space analysis, formulation positioning, and identification of potentially defensible approaches based on the data generated in the lab. It is a tool that gives outside patent counsel a stronger technical foundation to work from. It is not a freedom-to-operate opinion, a filing strategy, or a substitute for the work of a registered patent attorney. The consultant’s relationship with the client’s IP counsel is unaffected by Callan’s involvement.
Building the Relationship Before You Need It
The consultants who get the most value from working with Callan are those who know our capabilities well enough to recognize a fit quickly when a client program calls for it. That recognition is much easier when it’s not the first conversation.
If you work with early-stage biotech or pharma companies developing injectable or ophthalmic drug products, we’d welcome a conversation before you have an active referral in mind. Understanding what Callan can and can’t do, how our proposals are structured, and what our outputs look like takes one call. When the right client program comes along, you’ll already have the answer.
Let’s Talk
Reach out any time to start a conversation. We’re glad to walk through our capabilities before you have a specific program in mind.
