Moravek

Moravek is a leader in API GMP solutions, specialising in the preparation of 14C and 3H radiolabeled active pharmaceutical ingredients (APIs) for Phases 0, I, and II mass balance and microdosing studies. The company excels in providing good manufacturing practice (GMP) synthesis, purification, testing, and quality assurance release in compliance with FDA guidelines for these phases. Moravek operates under ICH Q7 Section 19, ensuring that all radiolabeled APIs produced are thoroughly analysed using qualified analytical instrumentation. Each batch is supplied with a comprehensive batch record that details the entirety of the synthetic, purification, and analytical processes.

Services include:
- cGMP Synthesis
- Chemical Analysis
- Chromatography
- Clinical Trials
- Contract Manufacturing (CMO)
- Manufacturing
- Custom Synthesis
- APIs (Active Pharmaceutical Ingredients)
- Controlled Substances
- Mass Spectrometry
- Microdosing
- Organic Synthesis
- Purification
- Quality QA/QC
- Radiopharmaceuticals
- Stability Studies
- X-Ray Powder Diffraction
- Regulatory Services
- Containment
- Analytical Services

Moravek stands out for its commitment to quality and regulatory compliance in the pharmaceutical industry. For additional information, please visit moravek.com.