Bio Analytical

Lambda is one of the most experienced Bioanalytical service providers in India. We provide services from two strategic locations in India and Canada. A highly qualified and experienced team of over 150 research professionals work round the clock and have helped accumulate an expansive assay catalogue of more than 850 validated methods.

 

Our GLP certified labs. are equipped with cutting edge, highly sophisticated instruments such as LC-MS/MS (40+ machines).

 

With over 850 validated methods and more than 10 methods at various stages of development at any given point of time, Lambda is perfectly geared up to handle your bio-analytical requirements. Lambda’s bio-analytical experts are capable of developing and validating new methods in a time span of approximately 06-08 weeks. We have experience in undertaking bioanalysis for pre-clinical / Toxicity studies and have developed methods for cocktail assays. The average reanalysis required is in less than 5% of the total samples. We are proud to state that a large part of our scientists of this team have been associated with us for over 8 years and come with a wealth of experience that enables us to successfully develop and validate even the most challenging of methods. Lambda has sensitive methods available with an LLOQ as low as 0.5 pg/mL. We have developed sensitive methods for NCEs in different species like Rat, Mice, Dog and Monkey using low sample volume.

 

Samples are stored in controlled and monitored low temperature storage ranging from -22±5°C, -65±10°C. Lambda’s freezers have a capacity to store 3 million samples.

 

Our vast expertise and in-depth understanding of stringent regulatory requirements ensure each project is accomplished in rapid turn-around times. We are proud to be a partner for several prominent generic pharma companies and have helped contribute to their aggressive First To File projects timelines by speedy bioanalysis in line with their requirements.

 

We have also successfully cleared 50+ Global regulatory inspections from FDA, EU, MHRA, ANVISA, ANSM, to name a few. Our Method Validation SOPs are in compliance with all major regulatory requirements. We have Global SOPs in place for all major bioanalytical processes.

 

The BA teams in India and Canada have robust knowledge sharing transfer procedures in place to assist any location in coming up to speed whenever a method transfer is needed from one location to the other on an urgent basis.

 

Our Bioanalytical forte can be summarized as:

  • Pre clinical assay capabilities
  • 850+ validated methods
  • High sensitivity instruments (API 6500 / XEVO TQS)
  • GLP certified Bioanalytical labs
  • Capabilities of analyzing 75,000+ samples per month on 40+ LC-MS/MS

 

Our BA scientists regularly attend several major bioanalytical forums held during the year to keep themselves abreast with the latest in this field. Lambda is a member of the Global CRO Council (GCC). Market Intelligence by Lambda’s inhouse Market Intelligence team of experts develop trend projections for First to File molecules and molecules going off patent that assist the BA team in proactively developing several methods to service the needs of the market. The team regularly contributes to posters presented at scientific conferences and pens various blogs that are available on the Lambda website as well.

 

Visit our Bioanalytical blog here: http://www.lambda-cro.com/bioanalyticalblog/

Click here for the latest validated assay list: http://www.lambda-cro.com/assay-list/