Navitas Life Sciences offers a portfolio of laboratory services. We own two of the ten CAP accredited labs in India situated in Whitefield, Bangalore, and Kasturba Hospital, Manipal. Our labs are accredited by both the College of American Pathologists (CAP) and the National Accreditation Board for Testing Laboratories (NABL) of the government Department of Science & Technology pursuant to ISO 15189.
We participate in national and international EQAS programs. By implementing standards and systems which comply with CAP and ISO standards from sample transport to reporting, we ensure that we have a world class system capable of withstanding the most rigorous audit requirements.
Navitas Life Sciences offers world class services for
- Central Lab testing service for Patient Clinical Trials
- Safety testing for normal healthy volunteers for BA/BE studies
- Pharma company research testing including biomarker validation
- Bio-analysis for bio-similar compounds through our partners.(Peg, GCSF, mAbs)
- Anti Xa & Anti IIa testing on low molecular weight heparin
- Post vaccine immunogenicity testing (Rubella, Diphtheria, Pertussis, Tetanus antibodies
- Esoteric testing for nutritional industry
- Occupational Health testing for lead, heavy metals etc
We conduct pharmacokinetic studies and offer custom tailored studies using molecular and cellular sciences.
Central Lab Testing Service for Clinical Trials
Navitas Life Sciences provides laboratory services at all stages of clinical development.
A dedicated project coordinator studies the requirements specific to a trial, designs lab kits, labels, and sample collection tubes along with pre-approved shipping labels and documents and ships them in visit-wise shipping containers. Once the samples are received we report within a specified turnaround time. Both sites and sponsors can peruse results on the web using password-enabled access. As a standby measure we also send the generated report by fax and email.
We will customize lab services to suit our sponsor's needs. We offer project management services which include test design & statistical validity, regulatory consultation, import of kits, reagents, investigator briefing, providing central lab testing service and archival. We deploy contemporary 21 CFR part 11 guidelines compliant with LIMS-STARLIMS functioning on an Oracle database. A validated LIMS system facilitates electronic sample logging and tracking as well as logistic supplies.
Testing for Global Studies
We are part of global laboratory networks with compatible labs in Europe, USA and Australia.
Our alliance with the leading labs in the above regions benefit the sponsor with faster turnaround time for reporting, reduced cost of sample shipment, easy regulatory clearance and reduced time for data clarification.
We have conducted inter-laboratory harmonization with LKF(www.lkf-kiel.de) and Interlab network (www.interlab.de), which allows testing inside Europe, USA (Spectra Clinical Research) and inside Australia.
We have managed over 25 clinical trials and over 130 PK/PD studies.
Pharma Company Research Testing
We have a team of scientists and clinicians who can design tests to find answers to your special inquiry. Drug-to-drug reaction, efficacy in a genetic type, immunology, HLA matching and biomarkers are some areas where we can provide insight. Our biostatisticians can advise on sample size. For pharma and biotech clients we offer custom tailored studies using molecular and cellular sciences.
The Navitas Life Sciences Team Advantage
Located in the science and knowledge capital of India, we are in a unique eco-system that enables us to assure quality at an affordable cost and deliver accurate reports on time. Harmonized with laboratories in Americas, Europe and SEA, we can manage global Central Lab services for pharma and bio-pharma clients.
When a EMA Post-Authorization Safety Study required the analyses for heavy metals in bone and skin samples from 8 countries of Europe, US, Asia we rose to the challenge. We developed a GLP compliant method, collected samples from across the globe, arranged logistics, and obtained export and import permits to the satisfaction of sponsors.