Pharm-Eco expands service offerings
Devens, MA – Pharm-Eco, a Johnson Matthey Company and part of Johnson Matthey’s Pharmaceutical Materials Division, announced today that their Analytical/Quality Control and Regulatory Compliance services, which were previously offered in conjunction with existing project contracts, will now be offered independently as well.
Pharm-Eco is an outsourcing company that enables their clients to succeed in their discovery, development and production of API by getting them to market faster through innovative, cost efficient chemistry services. Their service areas encompass the entire drug development cycle, from early stage discovery through commercial manufacturing.
Addressing the growing needs of the industry, the new independent service offerings will be modeled after Pharm-Eco’s exemplary, rigorous in-house Quality system that is currently used for all existing projects. Analytical/QC services include analytical methods, analytical method validation, analytical method transfer, compendial testing, impurity profiles, impurity identification, reference standard development and characterization, structure elucidation, and stability services.
Amongst the Regulatory Services are support for Investigational New Drug Applications (INDs), New Drug Applications (NDAs), and Abbreviated New Drug Applications (ANDAs); Authoring the Chemistry and Manufacturing Controls (CMC) section of regulatory filings, providing sections of the filing, or performing a compliance review; Authoring Type II Drug Master Files (DMFs) and providing letters of reference; Obtaining cGMP certificates for drug substance as well as filing compendial monographs in the US and Europe.
Pharm-Eco will also provide auditing services utilizing a combined 60+ years of expertise in that area. Rounding out the service offering will be training services based on Pharm-Eco’s highly developed training modules in all critical areas of operations.
For more information on this or other services provided by Pharm-Eco, please contact Harwood “Woody” Stiles, Director, Quality at 978-784-5000.
