Semler Research Center Is A Clinicalresearchorganizations, Clinicalresearchcro,contractres

SRC offers the Fast, Efficient & Accurate Bioanalytical services providing exactly the support needed to accelerate your drug development at every stage.

We bring outstanding bioanalysis support to your research through extensive expertise, comprehensive scientific capabilities, responsive communication, and a commitment to information technology and client service and state-of-the-art technology.

Working Principle

- Every project is customized to the individual needs of the client by providing personalized service and data of the highest quality. The scientist assigned as Study Director oversees all phases of a project, from receipt and inventory of reference materials and samples to preparation of the final report. We guarantee that each client will have direct access to the scientist who is most intimately involved with the client's project.
- Strict security and confidentiality policies and procedures are applied to all analytical work to ensure that each client receives services of the highest integrity.
- Studies are being performed in compliance with international guidelines and rules.
- Bioanalytical methods are developed and validated in compliance with GLP rules and ICH/FDA guidelines.
- To view the FDA guidances, click below:
http://www.fda.gov/cder/guidance/4252fnl.pdf
- 21 CFR Part 58 Good Laboratory Practices: Guidance for Industry Bioanalytical Method Validation
http://www.cfsan.fda.gov/~dms/opa-pt58.html

Strength and Capability

Our ability to meet and exceed the expectations of our pharmaceutical clients is directly tied to the expertise and responsiveness of our staff. We recruit the most qualified personnel and provide them with a work environment and the resources that result in a high level of achievement and job satisfaction. All projects are managed by scientists with extensive bioanalytical experience. Our Study directors are also directly involved in method development and validation through sample analysis, providing a degree of integration..

Operations

- Fully secured facilities monitored with access controls and cameras.
Uninterrupted Power Supply (UPS)-protected laboratory instrumentation.
- Ocea Soft wireless monitoring system - Environmental and instrument monitoring with alarm and mobile alarm system.
- Full backup - Daily, Weekly, monthly and Off site back up.
- Years of experience allows Tandem Labs to have highly efficient, streamlined, and strictly GLP-compliant SOPs.

GLP Bioanalytical Services

Method development Method validation in accordance with

- United States Food & Drug Administration (FDA)
- Organization for Economic Cooperation and Development (OECD)
- Japanese Ministry of Health, Labor, and Welfare (MHLW)

Bioanalysis

Acceptance criteria are fixed as per SRC SOPs and the FDA's Guidance for Industry for Bioanalytical Method Validation, Section VI, Application of Validated Method to Routine Drug Analysis.

- Pre-clinical and clinical sample analysis
- Complete bioequivalence studies in man or animals
- Pharmacokinetic/ toxicokinetic studies
- Drug and metabolite assays in different biological matrices
- Development and validation of bioanalytical methods

SRC facility

- 8,000 square feet of dedicated laboratory and office space.
- Both Sciex and Micromass instruments are used in order to ensure the best available methodology for a particular application. This new facility allows for instrument capacity capable of analyzing in excess of 800 samples per day.
- MDS Sciex API 3200 MS/MS systems 2 nos
- Waters Quattro micro with UPLC as front end 1 no
- Water purification system Millipore RiOs 16 and Milli-Q
- Deep Freezer boxes with temperature control with GSM alarm system

Equipment

- HPLC(Waters, Alliance 2695)
- UPLC(Waters)
- LCMS/MS(Waters,Quattro Micro API)
- LCMS/MS (Applied Bio Systems Api 3200)
- Refrigerated Centrifuge (Hettich)
- ULTF(-800C and -200C))(Dairei)