Precision-driven drug development
Pharmaceutical Research
CMC Development and Research
Drug development from start to scale
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
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
Synthesis Optimization
Refining synthetic processes for efficiency and scalability.
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.
From concept to clinical readiness
Medicilon’s formulation development services enable innovative and effective drug delivery.
solutions
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.
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.
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.
