CMC Support

CMC is one of the most complex and critical areas of ATMP development, where getting it right means starting early. We help build regulatory-aligned, future-ready CMC strategies to reduce risk and accelerate progress to clinic and market.

Reduce risk from the start
Accelerate clinical readiness
Adapt as you grow and develop

Let's discuss how we can suppport your CMC strategy!

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CMC and Regulatory Support That Matches Your Stage

We work with early-stage ATMP developers to help build compliant and scalable CMC and regulatory frameworks. Whether you need a full program or targeted input, we offer support through internal expertise and trusted external partners. Our services are normally available on a fee-for-service basis. In specific cases, such as incubation processes, support may be offered in-kind.

What to Expect from Our CMC Support

We help ATMP developers establish a solid CMC foundation early on, ensuring compliance, efficiency, and smoother progress towards the clinic.

Identify Risks Early

Find potential deficiencies in your CMC program before they cause delays. Our analysis provides clear actions to de-risk and optimise your development.

Strengthen Your Control Strategy

Apply proven principles to build a robust control framework that secures product quality, safety, and efficacy across development stages.

Navigate Regulatory Pathways

Get strategic support to align your CMC work with regulatory expectations, from scientific advice to submissions.

CMC Strategy Is Central to ATMP Success

To develop a market-viable ATMP, a regulatory-compliant and future-proof CMC package is essential. It enables progress into clinical trials and, eventually, marketing authorization.

A CMC gap analysis identifies deficiencies and risks in your development program. It helps you to focus resources, reduce delays, and ensure that product development progresses cost-efficiently and at the right regulatory pace.

For ATMPs, which are inherently complex and variable, developing a robust control strategy is critical. Using elements of Quality by Design (QbD) improves product and process understanding, supports comparability when changes occur, and strengthens quality, safety and efficacy across the product lifecycle.

Our Expertise

We support ATMP developers to build a robust CMC and regulatory framework to ensure compliance and accelerated product development. To do this we utilize a mix of internal competencies and external partners to provide you with the most suitable support. Our services include:

Gap Analysis

We assess your current CMC program to identify deficiencies, risks and potential delays. Delivered as a stand-alone service or part of a broader engagement, our gap analyses help clarify priorities and support the development of robust, cost-efficient CMC strategies.
CMC Strategy Development

We support the development and implementation of CMC strategies tailored to your product and development stage. This may include control strategy development using QbD principles, QTPP definition, CQA, CPP and CMA identification, and comparability strategy design.
Regulatory Support

We offer regulatory support throughout clinical and non-clinical development. This includes regulatory strategy, gap analyses, assistance with scientific advice, and guidance for regulatory submissions — all aligned with evolving ATMP requirements.

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