CRO, CDMO
At Chemex Global, we are committed to accelerating your pharmaceutical journey from concept to commercialization. As a trusted Contract Development and Manufacturing Organization (CDMO) and Contract Research Organization (CRO), we offer end-to-end solutions tailored to the unique needs of pharmaceutical and biotech companies worldwide. Specializing in comprehensive services focused on Active Pharmaceutical Ingredient (API) & intermediates development, we support your pharmaceutical innovations with robust scientific expertise and strong regulatory foundations.
Our Comprehensive Services
1. Custom Synthesis and Process Development
- Route Design and Optimization : We develop and refine synthetic routes to ensure efficient, scalable, and cost-effective API production processes.
- Analytical Method Development : Our experts create and validate analytical techniques to guarantee consistent quality and performance of APIs across all development stages.
2. Technology Transfer and Scale-Up
- Pilot Scale Production : We facilitate smooth transition from lab-scale to pilot-scale, resolving scalability and reproducibility challenges.
- Process Validation : We perform thorough validation to confirm that manufacturing processes reliably produce APIs that meet defined specifications.
3. Manufacturing Excellence
- Synthesis of APIs and Intermediates : Our state-of-the-art facilities support complex chemical syntheses, delivering high-purity Active Pharmaceutical Ingredients (APIs) and intermediates.
- Commercial Manufacturing : From pilot-scale to full-scale production, we provide flexible manufacturing solutions that meet stringent quality standards.
- HPAPI Handling : We offer safe and compliant production of High Potency APIs using advanced containment technologies and strict handling protocols.
4. Regulatory and Quality Support
- Regulatory Affairs : Our knowledgeable team guides global regulatory submissions, ensuring alignment with FDA, EMA, and other international bodies.
- Quality Assurance and Control : We implement robust quality systems to uphold product safety, consistency, and compliance throughout all phases of development and manufacturing.
5. Packaging and Logistics
- Pharmaceutical Packaging : We offer tailored packaging solutions that comply with regulatory standards and maintain product integrity.
- Global Supply Chain Management : Our end-to-end logistics services ensure secure, timely, and efficient global distribution of pharmaceutical products.
Why Choose Chemex Global?
At Chemex Global, we are dedicated to advancing your pharmaceutical projects with precision, efficiency, and compliance. Here’s why leading companies can trust us:
Integrated End-to-End Solutions: We offer seamless integration of research, development, regulatory support, and manufacturing services, accelerating timelines and simplifying project management.
Deep Expertise and Industry Knowledge: Our team of seasoned scientists and engineers brings extensive experience in organic chemistry, process development, and regulatory compliance, providing innovative solutions for complex challenges.
Commitment to Quality and Compliance: We operate under strict Good Manufacturing Practices (GMP) and international quality standards, ensuring the highest level of product integrity and regulatory readiness.
Client-Centric Approach: Your goals, timelines, and budget are our priorities. We deliver flexible, customized solutions that align with your strategic objectives, ensuring personalized attention at every stage.
Global Regulatory Insight: With deep understanding of international regulatory frameworks, we navigate global compliance requirements efficiently, supporting smooth market entry worldwide.
Partner with Chemex Global to bring your pharmaceutical innovations to life with scientific excellence, quality assurance, and global regulatory expertise.
Contact us today to learn how we can support your development, manufacturing, and commercialization success.
