Company record
Millennium Research Laboratories, Inc. delivers comprehensive research services for the pharmaceutical and biotech sectors, encompassing analytical, bioanalytical, chemistry, stability storage and testing, as well as formulation development. The firm’s contract portfolio includes methods development and validation, quality‑control testing, stability studies, synthetic chemistry, characterization services, and pre‑formulation evaluations. Within methods development and validation, it performs product‑release testing, dissolution testing, cleaning‑validation analysis, and other quality‑control assays using both specific and non‑specific approaches. Analytical capabilities feature FT‑IR, HPLC, NMR, SEM/EDXA, DSC, GC, LC, and Direct‑Probe MS, with all assays engineered to integrate seamlessly with LC‑MS techniques. Additional competencies cover laboratory data analysis, statistical interpretation of study results, preparation of manuscripts and technical reports to prescribed formats, batch‑record review, assay‑data evaluation, and the identification and isolation of measurable and trace impurities. Stability chambers are available in frozen, refrigerated, and all ICH‑specified temperature conditions. Millennium Research Laboratories, Inc. provides on‑time testing support for NDA, ANDA, and IND submissions, adhering to FDA and ICH guidelines while maintaining cGMP compliance.
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