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Chemistry, Manufacturing, and Controls (CMC) (Quality) Services

CMC Services to support biotech and pharmaceutical companies throughout the drug development lifecycle.

Comprehensive CMC (Quality) services to support every stage of the drug development journey

Drug development is an intricate process, with CMC challenges often being a key contributor to high attrition rates. Certara’s Chemistry, Manufacturing & Controls (CMC) Services address these complexities by focusing on the physicochemical properties of molecules early in development. This approach reduces attrition risks and fortifies your pipeline for long-term success.

Certara’s CMC experts provide tailored support across all development phases, including preclinical, clinical, and post-market stages. Our services include regulatory strategy preparation, CDMO evaluation, gap assessments, and advanced modeling tools to optimize outcomes for both small and large molecules.

Proven expertise across diverse modalities

Our team specializes in diverse therapeutic modalities, including biologics, cell and gene therapies, and small molecules.

Regulatory success track record

We have guided numerous clients to successful NDA approvals and clinical hold resolutions.

Advanced in silico modeling tools

Utilize Simcyp models like SIVA and PBPK to enhance early formulation selection and streamline regulatory processes.

End-to-end pipeline support

From preclinical planning to post-market changes, we provide holistic solutions to meet your unique CMC needs.

Why choose Certara for CMC services?

Certara offers unmatched expertise in Chemistry, Manufacturing & Controls, combining innovative tools and proven strategies to mitigate risks and drive success. With a client-focused approach and a legacy of regulatory achievements, we are your trusted partner in navigating the complexities of drug development.

Schedule a strategy session with one of our CMC experts

Specialized in silico model enabled CMC

Simcyp models – SIVA and PBPK
Early Formulation Selection, support biowaiver for manufacturing site and formulation chance, IVIVC, ‘Safe Space’ for critical attributes
Collaborations to link deep CMC development and unique in silico modeling expertise at Certara

Access to regulatory writing & scientific experts

20+ in-house regulatory writing experts
Module 3 for large & small molecules, complex biologics
Specialty experts in API chemistry, biologics, cell & gene therapy, pediatric formulations, long acting injectables, microbiome, CoGs
Scientific experts with former industry & government agency experience 

Contact us about our CMC services

Certara’s CMC consultants are ready to provide tailored strategies that address your unique development challenges. Reach out today to discuss how we can support your project no matter where you are in your development journey.

Expertise across all R&D phases
Proven track record of regulatory success
Advanced modeling tools for optimized outcomes

Schedule a strategy session


FAQs

What are CMC Services?

CMC Services encompass Chemistry, Manufacturing, and Controls processes crucial for ensuring product quality and regulatory compliance throughout drug development.

How does Certara support CMC challenges?

Certara provides tailored strategies, advanced modeling tools, and regulatory expertise to overcome complex CMC hurdles across all development stages.

What therapeutic modalities do you specialize in?

Certara specializes in small and large molecules, biologics, cell and gene therapies, and other advanced modalities.