Pharmalytica Services provides accurate, reliable, timely and cost-efficient contract analytical and manufacturing solutions to pharmaceutical and chemical industry clients. Our laboratories operate under full GLP and GMP compliance, are FDA registered and inspected and DEA licensed to handle, store and test Controlled Substances (Schedule I thru V).
We are a single source provider for your Drug Substance CMC section of your IND/CTA, NDA/MAA, DMF or ANDA; we provide a full range of GMP analytical services, including global stability programs, method development and validation, raw material release, drug substance and impurity characterization. In addition, we are a single source analytical provider for your Drug Product CMC section of your IND/CTA, NDA/MAA, or ANDA.
We offer both First-In-Human and Bioequivalency clinical trials through our established relationships with multiple clinical CROs.
Our Pre-clinical GLP services include pre-clinical formulation development, GLP analytical and bioanalysis support for toxicology, metabolism and clinical trials.
Oligonucleotide & Aptamer Analysis (PEGylated)
Oligonucleotide & Aptamer Analysis (Non-PEGylated)
Our EPA GLP services include conducting and supporting Environmental-Fate, worker exposure and leach rate studies.
In addition, we offer expert consulting and training in many areas, such as, GLP/GMP compliance, meeting CMC regulatory submission requirements, equipment qualification, process safety and facility audits.
New USP <467> Residual Solvents procedure! Pharmalytica is ready! Click the following link for more information.
New USP <467> Residual Solvents procedure
Please browse our website to learn more about how Pharmalytica Services can help you succeed!
