Regulatory/CMC Support
Bring the right expertise
into the plan.
DEP leads CMC regulatory strategy and coordinates expert review of development risks, solid-form changes, and the evidence needed for your next regulatory milestone.
Explore this service:
Your situation
When technical work must align with regulatory planning.
A solid-form change or an emerging development risk may affect specifications, the control strategy, or the evidence supporting the program. DEP brings together the appropriate CMC and regulatory judgment to assess these implications and coordinate the next steps.
Explore the approach and expertise
See how the work connects.
Read a fictional illustration of the team’s reasoning. It demonstrates an approach, not a client result or a fixed service package.
See how dependencies are coordinated →Relevant expertise
Profiles describe relevant experience. The people involved, their availability, and their roles are confirmed for each engagement.
Find a useful starting point
What do you need help with?
Answer two short questions to explore relevant support. This is a conversation guide, not a scientific assessment. You can contact DEP at any point.
Scope and delivery
Useful outputs. Clear responsibilities.
What you bring
The intended milestone and jurisdiction, current program plan, available technical reports, prior regulatory feedback where appropriate, and the responsibilities already held by your team or advisors.
What you receive
A CMC regulatory strategy or issue-specific assessment, review of implications for specifications and control strategies, a prioritized evidence-gap list, and recommendations on additional evidence or bridging considerations. Where needed, DEP coordinates the scientific rationale and questions for agency discussions.
Who does the work
DEP is your point of contact, assembles the relevant CMC and regulatory experts, and manages the review and project work. Experts interpret the technical evidence in the appropriate regulatory context; relevant providers contribute data and records. DEP integrates the findings into the program plan.
The recommendations follow the evidence, development stage, and regulatory context. A review may identify further work or questions for agency discussion; it does not predetermine an agency’s conclusion.
Connect solid-form evidence to the regulatory question.
DEP can coordinate the solid-state review and the CMC regulatory assessment as one project, so scientific findings inform the next development decision.
Explore scientific solid-form support →Before you spend, be sure™.
Start with the decision you need to make.
Tell us what you need help with, the question you have, or the milestone you’re working toward. DEP can help define the next steps and coordinate the work.
Drug Engine Pharma
You can contact DEP without sharing technical details.