Chemistry, Manufacturing, and Controls (CMC) Services
Chemistry, Manufacturing, and Controls (CMC) Services
Comprehensive CMC support for Biotech & Pharma across all phases of drug development
CMC Support Strengthens your Pipeline
Drug development is complex and high rates of attrition stem from a variety of factors. Chemistry, Manufacturing, and Controls (CMC) issues account for a significant attrition of the molecules during clinical development.
Hence it is paramount that proper attention is given at an early stage to the physicochemical properties to identify robust candidate molecules and formulations which could reduce the probability of attrition and enhance the strength of the pipeline.
Comprehensive CMC Services to Support Every Stage of the Drug Development Journey
Certara provides CMC support spanning from early preclinical development through Phase 3, Product Registration, and post-launch activities for both small and large molecules, and diverse routes of administration. The CMC strategy covers quality standards, regulatory meeting preparation and documentation (pre-IND, EOP2, pre-NDA/BLA, Type B/Type C), CDMO recommendation and evaluation, gap assessment, and due diligence of potential opportunities to name a few.
Discovery
- Pre-IND CMC Support
- Salt & Polymorph Selection
- BCS/ Bioenhancement
- Formulation Selection
- In silico/ Model-informed CMC Support
- Phase 1 Specs & Methods
- Early Stability
- Early Clinical Trial Supplies
- Bioanalytical Assay Development
Pre-clinical
- ID key starting materials for API, raw material suppliers
- Tech transfer
- Scale up
- Continue supplies for longer term tox/clinical
- Radiolabel material
- Analytical test method qualification and validation
Clinical
- First commercial image drug product design
- Pivotal trial supplies readiness
- Commercial supply chain
- Process qualification/validation batches campaign strategy
- Registration stability
- NDA/BLA package prep
Post-market
- Addressing agency questions (Information Request, CRL)
- Bridging/ Biowaiver Strategies
- Support post-approval CMC changes
- Formulation support for product line extension (PLE)
Certara CMC Consultants Support Small and Large Molecules
Our Key Consulting Services
Drug Substance
- Drug substance synthesis, starting materials, cost of goods
- Physico-chemical characterization
- Upstream and downstream processing (for biologics)
Drug Product & Delivery
- Multiple dosage forms-oral, parenteral, topical, transdermal
- Specialized formulations- bio-enhanced, long acting injectables, combination products, pediatric formulations, lyophilization, aseptic fill/finish
Analytical & Quality
- Phase appropriate analytical method development
- Phase appropriate API/drug product release specifications
- Process development & quality by design (QbD)
Strategy
- CMC project stewardship
- CDMO evaluation and oversight
- Strategy for biowaiver, bioequivalence, and IVIVC
- Due diligence
- Manufacturing/supply chain
- Comparability evaluation (for biologics)
규제
- Pre-IND, EOP2, NDA filing prep support
- Interaction with regulatory agencies
Benefits of Working with our CMC Development Strategy Team
Our team of CMC consultants offers extensive industry experience and expertise across the entire R&D pipeline, working with diverse modalities. We have a proven track record of successful NDA approvals and clinical hold lift-offs, which we will bring to your project.
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
Meet our CMC Consulting Experts
Deven Shah, PhD
Senior Director, Integrated Drug Development
Deven Shah is Certara’s Chemistry, Manufacturing & Controls (CMC) lead helping clients with their drug development CMC needs. Deven also supports the Certara Global Health practice area spending a significant amount of time attending to the Bill & Melinda Gates Foundation work.
Before joining Certara, Deven held positions of increasing responsibility and most recently as the Head of Pharmaceutical Development at Noven Pharmaceuticals and CMC/Preclinical Development Leader at GSK. Deven’s impressive background includes extensive experience leading cross-functional matrixed teams comprising of senior leads and hands on experience of CMC development across all phases in formulation development & drug delivery for diverse routes of administration & therapy areas. He also has extensive experience with conducting due diligences, managing biotech alliances, & identifying potential CROs for robust product development. Deven has contributed to regulatory filings spanning from pre-IND to NDA filing stage as well as represented organizations in the regulatory interactions with global agencies.
Deven received his B.Pharm from Jadavpur University in Calcutta, India and Ph.D. (Pharmaceutics & Drug Delivery) from the University of Southern California. He was the recipient of the Procter & Gamble award for excellence in graduate research in Pharmaceutics and Drug Delivery for his Ph.D. work.
Hien-Anh (HA) Bruno, PhD
Associate Director
Dr. Hien-Anh Bruno is an Associate Director in the Certara’s Chemistry, Manufacturing & Controls (CMC) group
Hien-Anh (HA) focuses on technical operations for novel therapeutics discovery and development, with an emphasis on clinical bioanalytical assays and CMC manufacturing processes across all therapeutic modalities (complex biologics, cell and gene therapies as well as small molecules).
HA works closely with toxicology, regulatory strategy and clinical pharmacology teams to ensure all aspects of CMC plus bioanalytical assays are compliant and ready for clinical trials and global regulatory submissions.
She has a track-record of building multiple teams/facilities, leading projects spanning from discovery, pre-clinical assessment to cGMP drug manufacturing, and has helped 40+ clients in developing and validating clinical PK/PD/ADA assays. Prior to joining Certara, she led the CMC team at Aceragen, managed the core R&D services at Exicure, assembled the tissue culture division at SAMDI Tech (a Charles River company), and led technical operations at Enzyme by Design Inc.
She obtained her PhD in Biochemistry at the University of Grenoble, her first postdoc training in System biology and Bioinformatics at the Institute Curie, and her second postdoc training in Structural Biology at the University of Illinois at Chicago.
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