Advinus has re-launched its services for clinical sample analysis. Backed by our GLP accreditation and 11 years history of bioanalytical method development, validation and sample analysis, Advinus clinical bioanalysis of human samples, along with our other capabilities, extends our service platform from preclinical to early clinical development.
The Advinus Bioanalytical team has excellent scientific capability and experience. It has a proven track record of serving Large Pharma and Biotech for their non-clinical and clinical bioanalytical needs. Data can also be turned-around within 72 h of receipt of samples (along with preliminary PK analysis, if required) to support exposure-guided dose escalation studies. All logistics are project-managed and we assure you hassle-free service of importing clinical trial samples into India. Studies are performed in accordance with USFDA and EMEA bioanalytical guidelines.
Briefly, we can:
- Develop and validate new analytical methods for NCEs using state-of-the-art LC-MS/MS & HPLC instrumentation and achieve sensitivity up to pg/mL levels.
- Validate an existing method already developed in another lab for application to study sample analysis.
- Quantify clinical trial samples for analyte and or metabolite(s) for Phase-I through Phase-III trials.
- Offer bioanalytical services for novel biologics and biosimilars using ELISA platforms.
For detailed information, read bio analytical services.