Navigate CMC demands for biologics and ATMPs
Quality is a critical pillar of every medicine, alongside safety and efficacy. From early development through commercialization and lifecycle management, CMC activities support the quality, consistency, and compliance needed to bring products to patients.
Cencora combines CMC strategy, scientific and technical expertise, authoring, and compliance support to help you navigate evolving requirements and maintain quality throughout the product lifecycle.
Cencora combines CMC strategy, scientific and technical expertise, authoring, and compliance support to help you navigate evolving requirements and maintain quality throughout the product lifecycle.
Address key CMC pressures in development and lifecycle
CMC requirements for biologics and ATMPs are detailed, evolving, and increasingly complex. With expert support across development, submission, and lifecycle management, you can reduce delays, compliance risk, and internal strain.
Regional requirements
Requirements vary across regions and product types, and ATMPs often need tailored development and regulatory strategies to support successful submissions.
Manufacturing variability
Variable starting materials and multi-step manufacturing processes require tight control, traceability, and comparability to maintain product quality.
Documentation gaps
Incomplete CMC documentation can trigger approval delays, health authority questions, clinical holds, and risk to marketing authorization.
Comprehensive CMC support for biologics and ATMPs at every step
Our CMC experts and specialists support your strategy from early development through dossier submission and post-approval lifecycle management.
Cencora provides strategic consulting, scientific and technical writing, and compliance support that helps keep your program moving while reducing regulatory and quality risk.
What we offer
CMC strategy
Regulatory strategy, intelligence, and development planning from preclinical and clinical phases through lifecycle management.
Dossier authoring
Preparation, review, and authoring of quality sections for clinical trial, investigational, marketing, and biologics license applications.
Technical writing
Scientific and technical documentation including expert reports, risk assessments, and health authority briefing materials.
Change control
Support for manufacturing changes, comparability exercises, site transfers, market expansions, and regulatory implementation.
Compliance support
Gap analysis, remediation planning, health authority commitments, and inspection-related CMC support.
Authority engagement
Scientific advice, agency interactions, deficiency response strategies, and support for health authority requests.
Why choose Cencora for CMC biologics and ATMPs
Global reach
Specialists across regions support your biologics and ATMP programs through development, submissions, and lifecycle activities.
Flexible delivery model
Centers of Excellence and specialized CMC teams help match support to your product, timeline, and regulatory needs.
Integrated support
Regulatory, CMC, publishing, quality, and lifecycle expertise work together to keep programs aligned and moving.
Expert insight
We have seen developers struggle with challenges related to donor selection and, notably, with CMC when shifting from research-grade to clinical-grade material, particularly around quality agreements with vendors.
— Michael Day, PhD
Breaking through early development challenges: BIO panel takeaways
Related solutions
CMC services
Get end-to-end Chemistry, Manufacturing, and Controls (CMC) support across product types, from early development through registration and post-approval lifecycle management.
Health authority interactions
We help life sciences teams navigate health authority interactions across development, review, and post-approval with clear strategy and actionable guidance.
PharmaLex is now Cencora
CMC biologics and ATMPs is part of our Commercialization support capability. Same team, same expertise, now with greater reach.
Need more information about CMC biologics and ATMPs?
Our team of experts is here to assist you. Whether you have questions or need more detailed information, don’t hesitate to get in touch. We’re dedicated to providing the support you need.