Numbers Speak

Establishing clientele in 2021

Years of Experience

Years in a Consultant Role

Satisfied Customers

Assets Across Product Development & Lifecycle

Providing support for your program priorities:

Creating Regulatory CMC Strategy

Phase appropriate, integrated and risk based CMC development, CMC development for accelerated programs, comparability assessments, innovation and platform concepts in CMC development, regulatory intelligence research, readiness for CMC development milestones (eg Product registration), regional considerations.

Module 3 and Related Documents

NDA, MAA: Phase appropriate core documents, regional considerations, sustainable CMC information in your application / license.

Successful Regulatory Interactions

Development of strategy for successful regulatory interaction: Overall strategy, briefing and meeting materials, preparation of your team for the interaction. Experience with FDA, EMA Scientific Advice, several EU National Agencies Scientific Advise, China NMPA, JPMA Quality Consultation, product and platform topics.

CMC Program Leadership

CMC regulatory lead, regional lead, CMC lead, project management, due diligence.

Technical Writing

Authoring of Module 2 & 3 based on technical documents. Authoring and review of internal technical reports.

Development of Control Strategy

Development of control strategy that encompasses Quality target product profile, CQAs, product and process risk assessments, specifications, comparability assessments.


Determine if Aurora CMC Consulting fits your needs.
For other questions

The needs for CMC consultancy services vary based on the priorities in question and organization needing the service. Therefore, there are no pre-defined packages offered. Examples of types of expertise provided are highlighted in ‘Services’. The scope-of-work, priorities, cadence, milestones and costs will be defined in our contract. Integration of our consultant to your development / asset / regulatory team may be relevant for priorities with broader scope. Where the SOW defines work that does not warrant integration of the consultant into routine team interactions (e.g. authoring of Module 3 documents based on technical reports), we should look to define deliverables and timelines based on overall program priorities and target timelines and completeness of your CMC package.

Good clarity on client’s priorities, state of development, timeline, and SOW from the start will give a good baseline for us to define optimal touchpoints and metrics for our collaboration. Routine check ins to ensure our work supports Client’s priorities in synchrony with overall program goals through preferred medium (meetings, live-edit documents, trackers, email, shared sites, etc) is recommended. While 2020 demonstrated that it is feasible to support most priorities remotely, Aurora CMC can attend face-to-face interactions when warranted. The preferred ways of collaborating can be pre-defined in our contract.

It is of interest for Aurora CMC to add value to your CMC priorities. We should discuss up front your CMC priorities and assess how/if Aurora CMC consultant can add value to your needs. Opportunities in new modality / drug delivery system where our consultant can add value to Client’s priorities based on their prior CMC experience, continuous learning, and their interest to contribute to CMC innovation can be prudent collaboration opportunities. Where Aurora CMC Consulting is unable to meet the needs of Client’s priorities, this will be communicated up front with a recommendation of other consultants from the network where possible.

Aurora CMC Consulting is a small consulting company that will strive to provide timely and high-quality services to the Clients. As a small company we will commit to SOW that we are able to deliver on and will inform clients in advance of out-of-office time to ensure transparency for milestone planning.

Our consultants are familiar with existing ICH Quality and many Health Authority issued CMC guidelines. The consultants monitor for developments in relevant guidelines and for hot topics by monitoring Health Authority communications, review of product assessment reports issued by HA and by participating in industry forums.

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