Comprehensive Chemistry, Manufacturing, and Control (CMC) Services
End-to-End CMC Solutions for IND-Ready and Clinical-Stage Programs
Speak With Our CMC Expert
CMC Development and Research
Drug Development from Start to Scale
>300,000 Sq Ft
50+
98%
2,000+
230+
Experts in API development, process optimization, and scale-up.
120+
Specialists in dosage form design, drug delivery systems, and clinical trial material preparation.
With significant investments in expertise and infrastructure, Medicilon’s CMC (Chemistry, Manufacturing, and Controls) division enhances every stage of the drug development process for optimal efficiency and compliance.
> 86,000
Designed for process development, optimization, and manufacturing
> 43,000
Supporting clinical trial material production with full GMP compliance
Our Expertise
Complete Lifecycle Management
One-Stop CMC Services
Comprehensive capabilities spanning API, formulation, analytics, stability testing, and GMP manufacturing under one roof.
Phase-Appropriate Strategy
Tailored CMC strategies that evolve from preclinical requirements through Phase I/II clinical trials and commercialization.
Seamless Transition
Integrated CRO-to-CDMO workflows designed to eliminate silos and minimize technology transfer risks.
Quality by Design (QbD)
Robust process and formulation development driven by QbD principles to ensure product quality and regulatory compliance.
Regulatory Excellence
Proven track record in supporting IND, NDA, and DMF submissions with global regulatory authorities.
Advanced Infrastructure
State-of-the-art GMP-compliant facilities equipped with cutting-edge analytical and manufacturing technologies.
De-risk Your Program with Seamless Tech Transfer
Moving from a CRO to a CDMO often leads to data loss and timeline delays. Our integrated model ensures your molecule’s knowledge history is preserved from the first gram to the final commercial batch.
- Unified analytical methods across phases
- Scalable equipment trains from pilot to commercial
- Single project management team
- Risk-based QbD approach to formulation
Core service area
Key capabilities for scalable drug development
Refining synthesis &
scale-up readiness
Medicilon delivers a full spectrum of API (Active Pharmaceutical Ingredient) process development services, guided by Quality by Design (QbD) principles.
solutions
Scale-Up Studies
Transitioning laboratory research to pilot and commercial-scale production (up to 300kg).
Manufacturing Process Validation
Ensuring robust and reproducible workflows.
Quality Control Implementation
Establishing rigorous measures for consistency and regulatory compliance.
Synthesis Optimization
Refining synthetic processes for efficiency and scalability.
From concept to clinical readiness
Medicilon’s formulation development services enable innovative and effective drug delivery.
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Innovative Drug Delivery Systems
Developing advanced delivery methods for enhance outcomes.
Dosage Form Design & Optimization
Refining forms for maximum efficacy and compliance.
Stability Studie
Conducting rigorous tests to ensure stability.
Clinical Trial Material Preparation
Producing compliant materials for clinical trials.
Maintaining quality at every stage
Medicilon ensures the highest level of compliance and reliability throughout.
solutions
GMP-Compliant Manufacturing
Maintaining consistent product quality.
Analytical Method Development
Creating and validating precise analysis methods.
Quality Control Testing
Thorough testing for consistency and safety.
Regulatory Documentation Support
Comprehensive management of regulatory submissions.
API Process Services
Refining synthesis &
scale-up readiness
Medicilon’s API Process Department provides end-to-end drug substance CMC services for innovative and generic programs, from route design and lab synthesis to scale-up and GMP manufacturing, aligned with global regulatory expectations.
- Class I ND
- Class II ND
- Process Change
- IND to DNA
- Preclinical Samples
- Phrase I Samples
- Phrase II, III Samples
- Advanced Intermediates
- Analytical Method Development and Validation
- Elemental Impurity Study
- Solvent Residue Study
- PSD/Crystal Form Study
- Genotoxicity Impurities Study
- Microbiological Research
- Drug Stability Research
- Process Safety Study
Specialized Platforms
API Process Development
Seamless process transfer to GMP manufacturing with full lifecycle validation support, ensuring your process works at scale, every time.
Clinical Readiness
Innovative Drug API Development
Laboratory process confirmation and parameter definition.
Non-GMP pilot batch production for early scale-up data.
Manufacturing of batches specifically for toxicology studies.
Full cGMP API production for clinical trials.
CMC documentation for China (NMPA) and U.S. (FDA) submissions.
Cost-Effective & IP-Aware
Generic Drug API Development & DMF Support
Route screening and optimization
API crystal form confirmation
Lab, pilot, & cGMP validation batches
Analytical method development
API stability studies
DMF preparation & CTD documentation
Regulatory Compliance
Expert support for China (NMPA) and U.S. (FDA) submissions with full CTD formatting.
Process Chemistry
Process Route Screening & QbD-Driven Optimization
Comprehensive Data-Driven Evaluation
Our approach goes beyond simple synthesis. We rigorously assess five key dimensions to tailor a stable, commercially viable route for your specific development stage.
Technical Feasibility
rigorous assessment of reaction kinetics, safety profiles, and critical process parameters to ensure reproducible results.
Supply Chain
Evaluation of raw material sourcing stability, cost-efficiency, and supply continuity for long-term manufacturing.
Scalability
Ensuring bench-scale chemistry translates seamlessly to pilot and commercial plant equipment without loss of yield.
Green Chemistry
Minimizing waste and solvent use to meet global sustainability standards and reduce ecological footprint.
IP Strategy
Comprehensive freedom-to-operate analysis to secure intellectual property and avoid infringement risks.
Optimizing Your Drug's Potential
Advanced Solid-State CMC Services & R&D Platform
R&D Core Platforms
Salt & Polymorph Screening
- Drugability improvement through form selection
- Strategic selection (Salt vs. Co-crystal vs. Free base)
- Patent strategy & breakthrough support
Crystallization Method Development
- Control of form, habit, and PSD
- Process efficiency & yield optimization
- High physical and chemical purity assurance
Single Crystal Structure Analysis
- Complete 3D structure elucidation
- Determination of absolute configuration
- Validated simulated XRPD pattern generation
Chiral Resolution
- Screening of optimal resolution agents
- Solvent system development for separation
- Enantiomeric purity maximization
Solid-State CMC Technical Services
We provide a full suite of patent-supporting technical deliverables and stability studies to ensure your molecule is ready for the next stage of development.
Screening & Recommendation
- Salt screening and salt form recommendation
- Polymorph and co-crystal screening
- Amorphous solid dispersion screening
Development & Scale-up
- Crystallization process development
- Process scale-up (Bench to Pilot)
- Solvent selection and optimization
Physicochemical Characterization
- X-Ray Powder Diffraction (XRPD)
- Differential Scanning Calorimetry (DSC)
- Thermogravimetric Analysis (TGA)
- Particle Size Distribution (PSD)
Stability & IP Support
- Solid-state and solution stability studies
- Patent-supporting technical deliverables
- Hygroscopicity assessment
Green Chemistry Platform
Biocatalysis & Sustainable Manufacturing
- KRED
- IRED
- NTR
- Esterase
- Amidase
- Transaminase
- Lipase
Greener Pathways Without Sacrificing Compliance
Biocatalysis offers a strategic advantage in modern API synthesis, delivering superior results while adhering to green chemistry principles.
Ready to Innovate?
Improve Selectivity
Enzymes offer exquisite chemo-, regio-, and stereoselectivity, reducing the need for blocking groups.
Mild Operating Conditions
Reactions proceed at ambient temperature and neutral pH, protecting sensitive molecular structures.
Reduced Waste
Minimize hazardous by-products and solvent usage, ensuring a smaller environmental footprint.
Integrated CMC Platform
Drug Product CMC & Formulation
Specialized Platforms
Advanced Drug Delivery Platforms
- Solid dispersion (HME, Spray Drying)
- Micronization & particle engineering
- Emulsions & solubilization tech
- In vitro dissolution & PK correlation
- Matrix & reservoir technologies
- Osmotic pump systems
- Pellet-based sustained release
- In vitro release method development
- Inhalation (DPI, Nebulizers, Nasal)
- Ophthalmic (Solutions, Suspensions)
- Transdermal & Topical (IVRT/IVPT)
- Micro/Nano particle systems
GMP Manufacturing & CRO-to-CDMO Integration
The integrated CRO-to-CDMO model reduces development risk, eliminates tech-transfer friction, and significantly shortens timelines.
Handling non-GMP & GMP pilot scale-up, Phase I/II clinical manufacturing, and flexible batch sizes.
Analytical & Quality
Advanced analytical laboratories and robust quality systems ensuring data integrity.
- Method Development
- Impurity Profiling
- Release Testing
- Stability Studies
- GMP QC Support
- CAPA Management
Regulatory & IND
Submission-ready CMC documentation aligned with FDA, NMPA, and global expectations.
- CTD Module 3 PreparationComprehensive documentation
- Dual Filing StrategyChina-U.S. simultaneous filing support
- Full Lifecycle SupportIND, NDA, DMF and post-approval changes
Specialized Platforms
Specialized platforms for precision development
Solid Form Screening Platform
Controlling the solid morphology of drug molecules for improved formulation performance.
Biocatalysis & Enzymatic Synthesis Platform
Enzyme research to GMP production, specializing in green biotechnology and high-end contract services.
Case Studies
Proven Results with Medicilon
Small-molecule New Chemical Entity (NCE)
Case 1: IND Completion in 12 Months (Small-Molecule NCE)
Medicilon delivered fully integrated, end-to-end CMC services for a small-molecule NCE, achieving IND approval within approximately 12 months from contract signing through a phase-appropriate, QbD-driven strategy aligned with FDA and NMPA expectations. By optimizing the synthetic route, executing GMP manufacturing, and preparing submission-ready CMC documentation, the program supported efficient parallel China–U.S. IND filings while minimizing regulatory risk.
Small-molecule API ; Solid State R&D Platform
Case 2: Route, Solid-State, and Impurity Optimization (Small-Molecule API)
Regulatory Support
Regulatory support simplifies your journey
Medicilon’s regulatory experts streamline the complex approval process, ensuring global compliance.
- IND filings for innovative drugs
- DMF submissions for generic drugs
- Adherence to NMPA, FDA, and international standards
Why Partner with Medicilon?
More than a service provider, Medicilon is your trusted partner in innovation. With 20+ years of experience, we integrate advanced technology, scientific expertise, and regulatory excellence to accelerate drug development success. Let us bring your vision to life.
Contact us today and take the next step with us.
Frequently Asked Questions
Have questions about CMC?
When should CMC planning begin?
CMC planning should begin as early as lead optimization to reduce downstream development risks and avoid avoidable rework before IND filing.
Can Medicilon support both API and drug product CMC?
Yes. Medicilon provides integrated drug substance and drug product CMC under one quality system for better coordination and fewer handoff errors.
Does Medicilon support FDA IND submissions?
Yes. Medicilon supports FDA, NMPA, and global submissions with CTD-compliant CMC documentation, including Module 3 readiness.
What does “phase-appropriate CMC” mean in practice?
It means aligning development depth to the program stage—enough to meet regulatory expectations now, while avoiding unnecessary cost until later phases.
How does CRO-to-CDMO integration reduce risk?
An integrated model reduces technology transfer gaps, improves continuity of data and process knowledge, and shortens timelines between development and GMP manufacturing.
Can you support DMF preparation for generic drug programs?
Yes. Medicilon supports DMF preparation plus CTD-formatted documentation for China–U.S. submissions, including stability and validation support.
