Advinus provides focused services for preclinical as well as early clinical development of drug candidates. We also have capabilities to provide support for drug discovery in the DMPK, Toxicology and Pharmaceutics areas. We are dedicated to reducing the time, cost and risks associated with drug development. Advinus works with clients and partners on a fee-for-service basis to supplement efficiencies and productivity in the development process. Advinus’ comprehensive platform of development services includes:

The Custom Synthesis laboratories at Advinus are fully equipped and manned by experienced scientific staff to constitute a seamless extension of client operations. With robust and streamlined processes for tight and transparent project management, Advinus supplements existing client capabilities to develop and build upon interesting leads. Our Custom Synthesis services include:

	Scale-up synthesis up to Kg and pilot scale
	Synthesis of NCEs and intermediates
	Salt and Polymorph selection

	Process research
	Process development and optimization
	Preparation of Analytical/ Technical Standards and Technical Package

Advinus chemistry and formulation services are fully supported by comprehensive and state of the art analytical capabilities. Our expertise includes physical and chemical characterization, stability analysis, impurity analysis, method development and validation for specification testing and bio-availability for organic and inorganic compounds. Advinus thus provides a single point centre analytical support for drug development. The full range of services includes:

	Method Development and Validation	Analytical Infrastructure and Equipment GC MS   LC MS   UV, IR   NMR   GC HPLC
	Characterization of Drug Substance
	Stability Testing
	Impurity Analysis and Profiling
	Preparation of Reference Standards

The bio-analytical team at Advinus has the expertise, technology and skills to deliver high quality data to support your research from the earliest phases. The range of services we offer can support research from preclinical to late-stage clinical trial support. We also offer our support for BA/BE studies. Method feasibility, development and validation support ensure superior bio-analytical services. Our dedicated scientists have both the experience and expertise for robust method development. The validated methods are applied by a highly skilled technical staff trained in the use of the latest equipment. Our SOPs and systems ensure compliance to EU, ICH and FDA requirements. The testing facility, lab, the softwares controlling various analytical equipment, the IT infrastructure and the management will ensure implementation of 21 CFR part - 11.

	LC-MS/MS systems (API 2000 & API 4000)
	HPLC with UV detectors
	Sample processing technologies
	Freezers (- 70° C and – 20° C)
	Scientific Data Management system

	Development and validation of Bio-analytical methods
	Adaptation and revalidation of sponsor’s assay methods
	Bioanalysis of drugs for pre-clinical and clinical studies

Advinus established a strategic partnership with Veeda- CR, a full-service Clinical CRO ( BA/BE , Phase 1 – IV & Data Management ) with global operations in November 2006. The alliance allows Advinus to extend our Drug Development capabilities to humans and leverages on Veeda's biomarkers capabilities for preclinical and clinical applications.

The integrated approach to Drug Development creates value for our Pharma and Biotech customers through packages involving preclinical and early clinical development, animal and human safety pharmacology, preclinical toxicology and pharmacology, clinical pharmacology as also microdosing capabilities to pick drug candidates on the basis of human PK data.

Click here for learning more about Veeda .

Advinus Management greatly emphasizes and values its independent Quality Assurance team, reporting directly to the CEO. A team of Quality Assurance personnel, entirely separate from and independent of the personnel engaged in the direction and conduct of the studies, conducts study based, process based and facility based audits / inspections routinely.

The QA team maintains copies of master schedule, SOPs and study protocols / plans for performing its functions in compliance with GLP principles. Draft and final reports of all studies are reviewed by QA personnel to assure GLP compliance, ensuring that the reported results accurately reflect the raw data of the studies conducted in the facility.