At Maqtox, we provide a comprehensive range of drug development services designed to advance your lead candidates from discovery through First-in-Human (FIH) studies. With a focus on delivering high-quality, cost-effective, and efficient solutions, we partner with clients to navigate the complexities of preclinical and clinical development.
Comprehensive Drug Development Solutions
Our drug development services cover every stage of the process, ensuring a seamless transition from lead optimization to clinical trials:
Synthesis and Characterization of API
- Development and production of Active Pharmaceutical Ingredients (APIs) with precise characterization and quality assurance.
Drug Metabolism and Pharmacokinetics (DMPK)
- Advanced studies to evaluate how your drug is absorbed, distributed, metabolized, and excreted.
- Identification of pharmacokinetic profiles to support dose selection and safety evaluations.
Safety and Toxicology
- Preclinical safety studies to assess the potential toxic effects of drug candidates.
- Comprehensive evaluations aligned with regulatory guidelines to ensure patient safety.
Chemistry, Manufacturing, and Controls (CMC)
- Optimization of formulation and manufacturing processes to meet global regulatory requirements.
- Ensuring consistent quality and scalability for clinical trials and beyond.
First-in-Human (FIH) Studies
- Execution of Phase 1 clinical trials to evaluate safety, tolerability, and pharmacokinetics in humans.
- Comprehensive data collection and analysis to support further clinical development.
Regulatory and Strategic Support
- Preparation of IND submission-ready documents, ensuring compliance with FDA and other global regulatory agencies.
- Direct interaction with regulatory bodies to facilitate approval and feedback processes.
Integrated IND-Enabling Services
Maqtox offers a fully integrated approach to support your entire Investigational New Drug (IND) enabling program. By consolidating services under one roof, we simplify project management, compress timelines, and reduce costs. Our team of experts works closely with clients to ensure all critical components of the IND package are completed with precision, including:
- Strategic consulting for regulatory and scientific requirements.
- Comprehensive testing and data analysis.
- Dedicated project management to streamline processes and maintain clear communication.
Why Choose Maqtox?
- Expertise Across Disciplines: With a team of seasoned professionals, we bring deep knowledge and experience to every project.
- Seamless Integration: Our end-to-end services are designed to streamline your drug development journey.
- Regulatory Excellence: We have extensive experience preparing and submitting IND applications for global markets.
- Efficient Project Management: A dedicated project management team ensures smooth coordination and timely delivery of results
Advancing Your Drug Candidate to Clinical Success
At Maqtox, we are committed to supporting your drug candidate’s journey from preclinical studies to Phase II trials. Our integrated services and client-focused approach ensure your success at every stage of the development process.
Partner with Maqtox to transform your vision into life-changing therapies. Together, we can bring innovative treatments to patients worldwide.