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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モデル - SIVAとPBPK
初期の製剤選択、製造拠点と製剤変更におけるバイオウェーバーのサポート、IVIVC、重要な特性のための「セーフスペース」
CMC開発と独自のin-silicoモデリングの専門知識を連携

薬事申請文書作成と各分野の専門家を紹介

20名以上の薬事・メディカルライター
大・小分子および複合型生物製剤用のモジュール 3
API化学、生物製剤、細胞・遺伝子療法、小児用製剤、長時間作用型注射剤
大手製薬企業および規制当局で経験を積んだコンサルタント

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

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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.

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