
CMC-Product Development & Manufacturing Services
At Maqtox, we deliver a comprehensive suite of Chemistry, Manufacturing, and Controls (CMC) services to support drug development at every stage from preclinical studies through formulation development, clinical trial manufacturing, and commercial product support. Our integrated approach ensures efficient, cost-effective, and high-quality outcomes for your product development needs.
Comprehensive CMC Services Portfolio
1.Preclinical to Phase III Support
- Pre-Formulation: Detailed assessment of the physical and chemical properties of drug candidates to guide formulation strategies.
- Drug Product Formulation Development: Expertise in creating optimized, scalable, and stable formulations tailored to specific therapeutic goals.
- Analytical Method Development and Validation: Rigorous analytical methods to ensure drug quality, stability, and regulatory compliance.
2.Clinical Trial Material (CTM) Manufacturing
- GLP and GMP Batches: Production of clinical trial materials under strict compliance with Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP).
- Scale-Up and Pilot Batches: Efficient scale-up processes to facilitate smooth transitions from lab-scale to commercial-scale production.
- Pivotal and Registration Batches: High-quality manufacturing to meet regulatory submission requirements.
3.Commercial Manufacturing
Ready to commence by Q3 2024, offering end-to-end solutions for large-scale production.
Specialized Capabilities
- Potent Compound Handling: Expertise in handling occupational exposure levels down to 1μg/m³ (Safebridge Category III) for high-potency compounds.
- DEA Licenses: Certified to handle Schedules I-V for analytical and manufacturing needs, ensuring secure and compliant operations.
Quality Assurance and Regulatory Excellence
- Regulatory Compliance: Adherence to ICH and US FDA GMP guidelines, ensuring that all processes meet global standards.
- Audits and Inspections: Facilities and processes undergo routine audits by sponsors and regulatory authorities, maintaining a consistent track record of compliance.
- Flexible SOPs: Standard Operating Procedures are adaptable to accommodate diverse client protocols and reporting formats.
The Maqtox Commitment
For over two decades, we have been a trusted partner in drug development, recognized for our collaborative approach, responsiveness, and ability to tailor services to meet the unique needs of our clients.
At Maqtox, our goal is to be more than a service provider—we are a partner in innovation, dedicated to advancing your product from concept to commercialization with precision and care.