Portrett Pharmaceuticals provides cGMP compliant analytical testing services to support small molecule drug development. Our capabilities include routine testing with guaranteed two week turnaround times, method development and validation, stability testing, compendial testing, and seamless method transfers. Learn more about them here.
Routine Testing:
We provide reliable and efficient routine testing services to ensure product quality, regulatory compliance, and consistency. Our fast turnaround times accelerate timelines for small molecule drug development, supporting key milestones like IND, NDA, and ANDA submissions.
Method Development:
Our team specializes in analytical method development and validation, ensuring accuracy, precision, and regulatory compliance. Services include phase-appropriate method development for FDA submissions, HPLC method development, and optimization tailored for small molecule programs.
Validation & Transfers:
Our team provides seamless method validation and method transfers, ensuring analytical methods are accurate, reproducible, and regulatory compliant. Our phase-appropriate method validation supports projects across all phases, from pre-clinical to phase III, with reliable oversight and results.
Compendial Testing:
Our team delivers comprehensive compendial testing services to meet global standards, including USP, EP, and JP compliance. Services include compendial method validation, testing for drug monographs, and quality control support for regulatory filings.
Stability Testing:
Our laboratory offers accelerated and long term stability testing to support small molecule drug products. With in-house qualified storage chambers and external partnerships, they provide stability analysis under various conditions.
Instrumentation & Equipment:
Our team is equipped with advanced analytical instrumentation and cutting-edge technology, ensuring precision and reliability in small molecule testing. A few of our capabilities include HPLC testing and precision analytical instruments.
Regulatory Support:
Our team is also experienced in complying with FDA regulatory requirements through precise testing services, supporting IND, NDA, ANDA, and other regulatory submissions. Our expertise in method validation, routine testing, and impurity analysis helps you meet your filing deadlines efficiently.
