Lambda Therapeutic Research

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Lambda Therapeutic Research Limited is a leading Global Clinical Research Organisation (CRO) established in 1999, providing full spectrum drug development services and bespoke services under the Clinical Research domain for all Pharmaceutical companies world-wide. [1] Lambda offers full spectrum clinical trial solutions empowered by more than 14 years of service to the biopharmaceutical and generic industry. At Lambda, our comprehensive services are executed with comprehensive efforts, to deliver positive results. Led by a management team of highly qualified & experienced industry leaders, we apply innovative technologies, therapeutic expertise and a commitment to quality in order to help clients develop products safely, effectively and quickly. [2]

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http://www.lambda-cro.com
Type Public / Private
Headquarters India
Number of employees 01-1000 employees


Services Offered

  • Bioanalytical
  • BA/BE
  • Phase I
  • Phase II-IV
  • Biometrics and Data Management
  • Pharmacovigilance
  • Medical Imaging
  • Biosimilars
  • Central Clinical Lab
  • Medical & Scientific Writing
  • Quality Assurance

Bio Analytical

Lambda is one of the most experienced Bioanalytical service providers in India. They 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.

Their 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. They state that a large part of our scientists of this team have been associated with them 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.

Their 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.

They have also successfully cleared 50+ Global regulatory inspections from FDA, EU, MHRA, ANVISA, ANSM, to name a few. Their 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.

Controversies

Top 5 Recent Tweets

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November 14, 2020MSamy_7@BSolomonsHood @7investing Actually, the Benchling Case Study: Using AWD Lambda, Amazon effectively cuts 90% of off… https://t.co/fLd23wI946


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Reference

  1. https://ph.linkedin.com/company/lambda-therapeutic-research
  2. http://www.lambda-cro.com/about-us-short/

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